Other products from "Z-MEDICAL GMBH + CO. KG"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 04057217001975 A06366_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
2 04057217002095 A06400_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
3 04057217002088 A06399_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
4 04057217002071 A06398_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
5 04057217002064 A06397_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
6 04057217002057 A06396_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
7 04057217002040 A06395_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
8 04057217002033 A06394_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
9 04057217002026 A06393_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
10 04057217002019 A06392_US NKB,MNI,MNH Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease,Orthosis, Spina Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease,Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation 2 NA
11 04057217002002 A06391_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
12 04057217001999 A06390_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
13 04057217001982 A06368_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
14 04057217001968 A06364_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
15 04057217001951 A06363_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
16 04057217001944 A06362_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
17 04057217001937 A06361_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
18 04057217001920 A06360_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
19 04057217001913 A06359_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
20 04057217001906 A06358_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
21 04057217001890 A06357_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
22 04057217001883 A06356_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
23 04057217001876 A06355_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
24 04057217001869 A06354_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
25 04057217001852 A06353_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
26 04057217001845 A06352_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
27 04057217001838 A06351_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
28 04057217001821 A06350_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
29 04057217001814 A06295_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
30 04057217001807 A06294_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
31 04057217001791 A06293_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
32 04057217001784 A06292_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
33 04057217001777 A06291_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
34 04057217001760 A06275_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
35 04057217001753 A06274_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
36 04057217001746 A06273_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
37 04057217001739 A06272_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
38 04057217001722 A06271_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
39 04057217001715 A06265_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
40 04057217001708 A06264_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
41 04057217001692 A06263_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
42 04057217001685 A06262_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
43 04057217001678 A06261_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
44 04057217001661 A06254_US MNH,NKB,MNI Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, F Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease,Orthosis, Spinal Pedicle Fixation 2 NA
45 04057217001654 A06253_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
46 04057217001647 A06252_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
47 04057217001630 A06251_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
48 04057217001623 A06495_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
49 04057217001616 A06494_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
50 04057217001609 A06493_US MNI,MNH,NKB Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Or Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 2 NA
Other products with the same Product Code "JDR"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B065EX075 EX075 ExoToe Staple 7.5 ExoToe EXOTOE, LLC
2 B065EX070 EX070 ExoToe Staple 7.0 ExoToe EXOTOE, LLC
3 B065EX065 EX065 ExoToe Staple 6.5 ExoToe EXOTOE, LLC
4 B065EX060 EX060 ExoToe Staple 6.0 ExoToe EXOTOE, LLC
5 B065EX055 EX055 ExoToe Staple 5.5 ExoToe EXOTOE, LLC
6 B04140037250 400-3725 400-3725 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
7 B04140037240 400-3724 400-3724 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
8 B04140037230 400-3723 400-3723 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
9 B04140037220 400-3722 400-3722 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
10 B04140037210 400-3721 400-3721 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
11 B04140037150 400-3715 400-3715 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
12 B04140037090 400-3709 400-3709 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
13 B04140037030 400-3703 400-3703 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
14 B04140037010 400-3701 400-3701 InstaFix Shape Memory Fixation System OT MEDICAL, LLC
15 M9703000112220200 3000-11-222020 DynaClip Bone Fixation System, Quattro, 22mm x 20mm x 20mm MEDSHAPE, INC.
16 M9703000112216160 3000-11-221616 DynaClip Bone Fixation System, Quattro, 22mm x 16mm x 16mm MEDSHAPE, INC.
17 M9703000111816160 3000-11-181616 DynaClip Bone Fixation System, Quattro, 18mm x 16mm x 16mm MEDSHAPE, INC.
18 M970300010321614120 3000-10-32161412 DynaClip Bone Fixation System, Delta, 32mm x 16mm x 14mm x 12mm MEDSHAPE, INC.
19 M970300010281614120 3000-10-28161412 DynaClip Bone Fixation System, Delta, 28mm x 16mm x 14mm x 12mm MEDSHAPE, INC.
20 M970300010241614120 3000-10-24161412 DynaClip Bone Fixation System, Delta, 24mm x 16mm x 14mm x 12mm MEDSHAPE, INC.
21 M9703000063020200 3000-06-302020 DynaClip Forte Bone Fixation System, 30mm x 20mm x 20mm DynaClip Forte MEDSHAPE, INC.
22 M9703000062620200 3000-06-262020 DynaClip Forte Bone Fixation System, 26mm x 20mm x 20mm DynaClip Forte MEDSHAPE, INC.
23 M9703000002620200 3000-00-262020 DynaClip Bone Fixation System, 26mm x 20mm x 20mm DynaClip MEDSHAPE, INC.
24 M9703000002022220 3000-00-202222 DynaClip Bone Fixation System, 20mm x 22mm x 22mm DynaClip MEDSHAPE, INC.
25 M9703000002018180 3000-00-201818 DynaClip Bone Fixation System, 20mm x 18mm x 18mm DynaClip MEDSHAPE, INC.
26 M9703000001820200 3000-00-182020 DynaClip Bone Fixation System, 18mm x 20mm x 20mm DynaClip MEDSHAPE, INC.
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28 M9703000001414140 3000-00-141414 DynaClip Bone Fixation System, 14mm x 14mm x 14mm DynaClip MEDSHAPE, INC.
29 M9703000001212120 3000-00-121212 DynaClip Bone Fixation System, 12mm x 12mm x 12mm DynaClip MEDSHAPE, INC.
30 M9703000001010100 3000-00-101010 DynaClip Bone Fixation System, 10mm x 10mm x 10mm DynaClip MEDSHAPE, INC.
31 M9703000000808080 3000-00-080808 DynaClip Bone Fixation System, 8mm x 8mm x 8mm DynaClip MEDSHAPE, INC.
32 M963224010 22401 22401 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum.Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x20x16mm with a 2.0mm x 3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide, 2ea 3.0mm diameter Kirchner wire with protective tips, 2ea 3.0mm Pull Pins; 1ea 3.0mm Drill Bit (color band of purple) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
33 M963220010 22001 22001 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Nitinol bone staple implant of dimensions 25 x 25 x 25mm with a 2.0mm x 3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with a lock pin, 1ea 25mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 3.0mm Pull Pins, 1ea 3.0mm Drill Bit (color band of purple). Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
34 M963219010 21901 21901 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x15x12mm with a 2.0x3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 3.0mm Pull Pins; 1ea 3.0mm Drill Bit (color band of purple) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
35 M963218010 21801 21801 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x30x30mm with a 2.0x3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 3.0mm Pull Pins; 1ea 3.0mm Drill Bit (color band of purple) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
36 M963217010 21701 21701 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x30x25mm with a 2.0x3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 3.0mm Pull Pins; 1ea 3.0mm Drill Bit (color band of purple) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
37 M963214010 21401 21401 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 09x09x09mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 09mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
38 M963213010 21301 21301 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 09x10x10mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 09mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
39 M963201030 20103 20103 Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula, and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol SuperSTEP™ staple implant of dimensions 20 x 20 x 20mm with a 10mm vertical step with a 2.0mm x 3.0mm leg diameter leg/bridge held in the instrument with a locking pin; 1ea 20mm spaced drill guide with step alignment pin, pre-assembled; 2ea 1.5mm diameter Kirchner wire with protective tips; 1 ea 3.0mm Pull Pin, 1ea 3.0mm Drill Bit (color band red). SuperSTEP™ METRIC MEDICAL DEVICES, INC.
40 M963200830 20083 20083 Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula, and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol SuperSTEP™ staple implant of dimensions 20 x 20 x 20mm with a 08mm vertical step with a 2.0mm x 3.0mm leg diameter leg/bridge held in the instrument with a locking pin; 1ea 20mm spaced drill guide with step alignment pin, pre-assembled; 2ea 1.5mm diameter Kirchner wire with protective tips; 1 ea 3.0mm Pull Pin, 1ea 3.0mm Drill Bit (color band red). SuperSTEP™ METRIC MEDICAL DEVICES, INC.
41 M963200630 20063 20063 Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula, and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol SuperSTEP™ staple implant of dimensions 20 x 20 x 20mm with a 06mm vertical step with a 2.0mm x 3.0mm leg diameter leg/bridge held in the instrument with a locking pin; 1ea 20mm spaced drill guide with step alignment pin, pre-assembled; 2ea 1.5mm diameter Kirchner wire with protective tips; 1 ea 3.0mm Pull Pin, 1ea 3.0mm Drill Bit (color band red). SuperSTEP™ METRIC MEDICAL DEVICES, INC.
42 M963175010 17501 17501 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x20x20mm with a 2.0x3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 3.0mm Pull Pins; 1ea 3.0mm Drill Bit (color band of purple) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
43 M963174010 17401 17401 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x20x20mm with a 2.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 2.4mm Pull Pins; 1ea 2.4mm Drill Bit (color band of red) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
44 M963173010 17301 17301 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 18x18x15mm with a 2.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 18mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 2.4mm Pull Pins; 1ea 2.4mm Drill Bit (color band of red) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
45 M963172010 17201 17201 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 15x12x12mm with a 2.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 15mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 2.4mm Pull Pins; 1ea 2.4mm Drill Bit (color band of red) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
46 M963171010 17101 17101 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 15x12x12mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 15mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
47 M963170010 17001 17001 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 13x10x10mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 13mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
48 M963169010 16901 16901 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 11x15x13mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 11mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
49 M963168010 16801 16801 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 11x10x10mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 11mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.
50 M963166010 16601 16601 Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 09x09x07mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 09mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow) Super Staple™ Classic METRIC MEDICAL DEVICES, INC.