Other products from "MEDSHAPE, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M97032000071100 3200-00-7110 HWC Screw, Fixation, Bone 2 DynaNail Helix, Headed, 110mm
2 M97032000170650 3200-01-7065 HWC Screw, Fixation, Bone 2 DynaNail Helix, Headless, 65mm
3 M97032000170550 3200-01-7055 HWC Screw, Fixation, Bone 2 DynaNail Helix, Headless, 55mm
4 M97032000071050 3200-00-7105 HWC Screw, Fixation, Bone 2 DynaNail Helix, Headed, 105mm
5 M97032000170950 3200-01-7095 HWC Screw, Fixation, Bone 2 DynaNail Helix, Headless, 95mm
6 M970300010241614120 3000-10-24161412 JDR Staple, Fixation, Bone 2 DynaClip Bone Fixation System, Delta, 24mm x 16mm x 14mm x 12mm
7 M97028000402009 2800-04-020 2.0mm Staple Pin, Reusable, Kitsune LXH Orthopedic Manual Surgical Instrument 1 Kitsune
8 M9702800040200 2800-04-020 2.0mm Staple Pin, Reusable, Kitsune LXH Orthopedic Manual Surgical Instrument 1 Kitsune
9 M9702800040150D 2800-04-015 1.5mm Staple Pin, Reusable, Kitsune LXH Orthopedic Manual Surgical Instrument 1 Kitsune
10 M9702800040150 2800-04-015 1.5mm Staple Pin, Reusable, Kitsune LXH Orthopedic Manual Surgical Instrument 1 Kitsune
11 M97028000302008 2800-03-020 2.0mm Staple Drill, Reusable, Kitsune HTW Bit, Drill 1 Kitsune
12 M9702800030200 2800-03-020 2.0mm Staple Drill, Reusable, Kitsune HTW Bit, Drill 1 Kitsune
13 M9702800030150C 2800-03-015 1.5mm Staple Drill, Reusable, Kitsune HTW Bit, Drill 1 Kitsune
14 M9702800030150 2800-03-015 1.5mm Staple Drill, Reusable, Kitsune HTW Bit, Drill 1 Kitsune
15 M9702800020250C 2800-02-025 25mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
16 M9702800020250 2800-02-025 25mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
17 M97028000202007 2800-02-020 20mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
18 M9702800020200 2800-02-020 20mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
19 M9702800020180E 2800-02-018 18mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
20 M9702800020180 2800-02-018 18mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
21 M97028000201208 2800-02-012 12mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
22 M9702800020120 2800-02-012 12mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
23 M97028000201006 2800-02-010 10mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
24 M9702800020100 2800-02-010 10mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
25 M9702800020080D 2800-02-008 8mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
26 M9702800020080 2800-02-008 8mm Staple Drill Guide, reusable, Kitsune LXI Guide, Drill, Ligament 1 Kitsune
27 M97028000100004 2800-01-000 Staple Sizer, Reusable, Kitsune LXH Orthopedic Manual Surgical Instrument 1 Kitsune
28 M9702800010000 2800-01-000 Staple Sizer, Reusable, Kitsune LXH Orthopedic Manual Surgical Instrument 1 Kitsune
29 M97015000200001 1500-02-000 Universal Tenodesis Disposable Procedure Pack KDD Kit, Surgical Instrument, Disposable 1 Eclipse
30 M9701500020000 1500-02-000 Universal Tenodesis Disposable Procedure Pack KDD Kit, Surgical Instrument, Disposable 1 Eclipse
31 M97015000109009 1500-01-090 Procedure Pack, 9.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
32 M9701500010900 1500-01-090 Procedure Pack, 9.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
33 M97015000108008 1500-01-080 Procedure Pack, 8.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
34 M9701500010800 1500-01-080 Procedure Pack, 8.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
35 M97015000107007 1500-01-070 Procedure Pack, 7.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
36 M9701500010700 1500-01-070 Procedure Pack, 7.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
37 M97015000106006 1500-01-060 Procedure Pack, 6.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
38 M9701500010600 1500-01-060 Procedure Pack, 6.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
39 M9701500010550A 1500-01-055 Procedure Pack, 5.5MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
40 M9701500010550 1500-01-055 Procedure Pack, 5.5MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
41 M97015000105005 1500-01-050 Procedure Pack, 5.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
42 M9701500010500 1500-01-050 Procedure Pack, 5.0MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
43 M97015000104509 1500-01-045 Procedure Pack, 4.5MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
44 M9701500010450 1500-01-045 Procedure Pack, 4.5MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
45 M97015000104004 1500-01-040 Procedure Pack, 4MM Sterile Cannulated Drill/Reamer HTW Bit, Drill Eclipse
46 M9701500010400 1500-01-040 Procedure Pack, 4MM Sterile Cannulated Drill/Reamer HTW Bit, Drill 1 Eclipse
47 M97015000009200A 1500-00-0920 ECLIPSE Soft Tissue Anchor, 9mm x 20mm MBI Fastener, Fixation, Nondegradable, Soft Tissue 2 Eclipse
48 M97015000009200 1500-00-0920 ECLIPSE Soft Tissue Anchor, 9mm x 20mm MBI Fastener, Fixation, Nondegradable, Soft Tissue 2 Eclipse
49 M97015000009150E 1500-00-0915 ECLIPSE Soft Tissue Anchor, 9mm x 15mm MBI Fastener, Fixation, Nondegradable, Soft Tissue 2 Eclipse
50 M97015000009150 1500-00-0915 ECLIPSE Soft Tissue Anchor, 9mm x 15mm MBI Fastener, Fixation, Nondegradable, Soft Tissue 2 Eclipse
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.
27 M9703000001818180 3000-00-181818 DynaClip Bone Fixation System, 18mm x 18mm x 18mm DynaClip MEDSHAPE, INC.
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.