Other products from "VILEX LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00841731120038 ST-102020 ST-102020 Staple, Nitinex 10x20x20mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
2 00841731120212 ST-152020 ST-152020 Staple, Nitinex 15x20x20mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
3 00841731120045 ST-122020 ST-122020 Staple, Nitinex 12x20x20mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
4 00841731119216 ST-A101311 Staple, Alpine 10x13x11mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
5 00841731114884 635T-40T Washer, 4.0mm Ti - T40 Screw HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
6 00841731114877 635T-30T Washer, 3.0mm Ti - T30 Screw HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
7 00841731114860 635T-20T Washer, 2.0mm Ti - T20 Screw HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
8 00841731114853 635-72T Washer, 7.2mm Ti Screw HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
9 00841731114846 635-65T Washer, 6.5mm Ti Screws .468x.275x.040 HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
10 00841731114839 635-65S Washer, 6.5mm SS Screw 468x.275x.040 HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
11 00841731114822 635-45T Washer, 4.5mm Ti Screw 328x.218x.040 HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
12 00841731114815 635-45S Washer, 4.5mm SS Screw 328x.218x.040 HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
13 00841731114808 635-40T Washer, 4.0mm Ti Screw 312x.175x.040 HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
14 00841731114792 635-40S Washer, 4.0mm SS Screw 312x.175x.040 HWC Screw, Fixation, Bone 2 Vilex Implant Accessory
15 00841731108432 ALD36-7U Plate, Avid Lapidus Med Angle HRS Plate, Fixation, Bone 2 Vilex AVID Plate
16 00841731106889 TH30-25T-1110 HammerFUZE Implant 3.0x25 Angled_Ti Magenta HWC Screw, Fixation, Bone 2 HammerFuze
17 00841731106872 TH30-25T-1100 HammerFUZE Implant 3.0x25 Str._Ti Magenta HWC Screw, Fixation, Bone 2 HammerFuze
18 00841731106865 TH25-20T-1110 HammerFUZE Implant 2.5x20 Angled_Ti Gold HWC Screw, Fixation, Bone 2 HammerFuze
19 00841731106858 TH25-20T-1100 HammerFUZE Implant 2.5x20 Str._Ti Gold HWC Screw, Fixation, Bone 2 HammerFuze
20 00841731106841 TH22-18T-0910 HammerFUZE Implant 2.2x18 Angled_Ti L.Blue HWC Screw, Fixation, Bone 2 HammerFuze
21 00841731106834 TH22-18T-0900 HammerFUZE Implant 2.2x18 Str._Ti L.Blue HWC Screw, Fixation, Bone 2 HammerFuze
22 00841731106827 ST-252222 Staple, Nitinex 25x22x22mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
23 00841731106810 ST-251616 Staple, Nitinex 25x16x16mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
24 00841731106803 ST-202020 Staple, Nitinex 20x20x20mm HWC Screw, Fixation, Bone 2 Nitinex Memory Staple
25 00841731106797 ST-201616 Staple, Nitinex 20x16x16mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
26 00841731106780 ST-181715 Staple, Nitinex 18x17x15mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
27 00841731106773 ST-181414 Staple, Nitinex 18x14x14mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
28 00841731106766 ST-181212 Staple, Nitinex 18x12x12mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
29 00841731106759 ST-151515 Staple, Nitinex 15x15x15mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
30 00841731106742 ST-151212 Staple, Nitinex 15x12x12mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
31 00841731106735 ST-121916 Staple, Nitinex 12x19x16mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
32 00841731106728 ST-121715 Staple, Nitinex 12x17x15mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
33 00841731106711 ST-121513 Staple, Nitinex 12x15x13mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
34 00841731106698 ST-101715 Staple, Nitinex 10x17x15mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
35 00841731106681 ST-101513 Staple, Nitinex 10x15x13mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
36 00841731106674 ST-101010 Staple, Nitinex 10x10x10mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
37 00841731106667 ST-081010 Staple, Nitinex 08x10x10mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
38 00841731106650 ST-080808 Staple, Nitinex 08x08x08mm JDR Staple, Fixation, Bone 2 Nitinex Memory Staple
39 00841731106315 CHI-5TH Cannulated Hemi Implant #5 24x21 Ti HA Coated Bronze KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
40 00841731106308 CHI-5T Cannulated Hemi Implant #5 24x21 Ti Bronze KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
41 00841731106292 CHI-5CH Cannulated Hemi Implant #5 24x21 CoCr HA Coated KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
42 00841731106285 CHI-5C Cannulated Hemi Implant #5 24x21 CoCr KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
43 00841731106278 CHI-4TH Cannulated Hemi Implant #4 22x19 Ti HA Coated Green KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
44 00841731106261 CHI-4T Cannulated Hemi Implant #4 22x19 Ti Green KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
45 00841731106254 CHI-4CH Cannulated Hemi Implant #4 22x19 CoCr HA Coated KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
46 00841731106247 CHI-4C Cannulated Hemi Implant #4 22x19 CoCr KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
47 00841731106230 CHI-3TH Cannulated Hemi Implant #3 19x17 Ti HA Coated Magenta KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
48 00841731106223 CHI-3T Cannulated Hemi Implant #3 19x17 Ti Magenta KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
49 00841731106216 CHI-3CH Cannulated Hemi Implant #3 19x17 Cocr HA Coated KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
50 00841731106209 CHI-3C Cannulated Hemi Implant #3 19x17 CoCr KWD Prosthesis, Toe, Hemi-, Phalangeal 2 Cannulated 1st MPJ Hemi Implant
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.