Other products from "NEOSTEO"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 33701173703276 S27TL40 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
2 33701173703269 S27TL38 S27TL38 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
3 33701173703252 S27TL36 S27TL36 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
4 33701173703245 S27TL34 S27TL34 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
5 33701173703238 S27TL32 S27TL32 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
6 33701173703221 S27TL30 S27TL30 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
7 33701173703214 S27TL28 S27TL28 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
8 33701173703207 S27TL26 S27TL26 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
9 33701173703191 S27TL24 S27TL24 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
10 33701173703184 S27TL22 S27TL22 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
11 33701173703177 S27TL20 S27TL20 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
12 33701173703160 S27TL18 S27TL18 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
13 33701173703153 S27TL16 S27TL16 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
14 33701173703146 S27TL14 S27TL14 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
15 33701173703139 S27TL12 S27TL12 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
16 33701173703115 S25TL40 S25TL40 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
17 33701173703108 S25TL38 S25TL38 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
18 33701173703092 S25TL36 S25TL36 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
19 33701173703085 S25TL34 S25TL34 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
20 33701173703078 S25TL32 S25TL32 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
21 33701173703061 S25TL30 S25TL30 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
22 33701173703054 S25TL28 S25TL28 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
23 33701173703047 S25TL26 S25TL26 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
24 33701173703030 S25TL24 S25TL24 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
25 33701173703023 S25TL22 S25TL22 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
26 33701173703016 S25TL20 S25TL20 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
27 33701173703009 S25TL18 S25TL18 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
28 33701173702996 S25TL16 S25TL16 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
29 33701173702989 S25TL14 S25TL14 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
30 33701173702972 S25TL12 S25TL12 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
31 33701173702958 S23TL14 S23TL14 Snap-off self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
32 33701173702941 S23TL13 S23TL13 Snapp-off self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
33 33701173702934 S23TL12 S23TL12 Snapp-off self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
34 33701173702927 S23TL11 S23TL11 Snap off self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
35 33701173702903 S21TL40 S21TL40 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
36 33701173702897 S21TL38 S21TL38 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
37 33701173702880 S21TL36 S21TL36 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
38 33701173702873 S21TL34 S21TL34 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
39 33701173702866 S21TL32 S21TL32 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
40 33701173702859 S21TL30 S21TL30 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
41 33701173702842 S21TL28 S21TL28 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
42 33701173702835 S21TL26 S21TL26 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
43 33701173702828 S21TL24 S21TL24 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
44 33701173702811 S21TL22 S21TL22 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
45 33701173702804 S21TL20 S21TL20 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
46 33701173702798 S21TL18 S21TL18 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
47 33701173702781 S21TL16 S21TL16 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
48 33701173702774 S21TL14 S21TL14 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
49 33701173702767 S21TL12 S21TL12 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
50 33701173702743 S19TL40 S19TL40 Self compressive screw HWC Screw, Fixation, Bone 2 Dynafit System
Other products with the same Product Code "JDR"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 M9703000112220200 3000-11-222020 DynaClip Bone Fixation System, Quattro, 22mm x 20mm x 20mm MEDSHAPE, INC.
2 M9703000112216160 3000-11-221616 DynaClip Bone Fixation System, Quattro, 22mm x 16mm x 16mm MEDSHAPE, INC.
3 M9703000111816160 3000-11-181616 DynaClip Bone Fixation System, Quattro, 18mm x 16mm x 16mm MEDSHAPE, INC.
4 M970300010321614120 3000-10-32161412 DynaClip Bone Fixation System, Delta, 32mm x 16mm x 14mm x 12mm MEDSHAPE, INC.
5 M970300010281614120 3000-10-28161412 DynaClip Bone Fixation System, Delta, 28mm x 16mm x 14mm x 12mm MEDSHAPE, INC.
6 M970300010241614120 3000-10-24161412 DynaClip Bone Fixation System, Delta, 24mm x 16mm x 14mm x 12mm MEDSHAPE, INC.
7 M9703000063020200 3000-06-302020 DynaClip Forte Bone Fixation System, 30mm x 20mm x 20mm DynaClip Forte MEDSHAPE, INC.
8 M9703000062620200 3000-06-262020 DynaClip Forte Bone Fixation System, 26mm x 20mm x 20mm DynaClip Forte MEDSHAPE, INC.
9 M9703000002620200 3000-00-262020 DynaClip Bone Fixation System, 26mm x 20mm x 20mm DynaClip MEDSHAPE, INC.
10 M9703000002022220 3000-00-202222 DynaClip Bone Fixation System, 20mm x 22mm x 22mm DynaClip MEDSHAPE, INC.
11 M9703000002018180 3000-00-201818 DynaClip Bone Fixation System, 20mm x 18mm x 18mm DynaClip MEDSHAPE, INC.
12 M9703000001820200 3000-00-182020 DynaClip Bone Fixation System, 18mm x 20mm x 20mm DynaClip MEDSHAPE, INC.
13 M9703000001818180 3000-00-181818 DynaClip Bone Fixation System, 18mm x 18mm x 18mm DynaClip MEDSHAPE, INC.
14 M9703000001414140 3000-00-141414 DynaClip Bone Fixation System, 14mm x 14mm x 14mm DynaClip MEDSHAPE, INC.
15 M9703000001212120 3000-00-121212 DynaClip Bone Fixation System, 12mm x 12mm x 12mm DynaClip MEDSHAPE, INC.
16 M9703000001010100 3000-00-101010 DynaClip Bone Fixation System, 10mm x 10mm x 10mm DynaClip MEDSHAPE, INC.
17 M9703000000808080 3000-00-080808 DynaClip Bone Fixation System, 8mm x 8mm x 8mm DynaClip MEDSHAPE, INC.
18 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.
19 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.
20 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.
21 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.
22 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.
23 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.
24 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.
25 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.
26 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.
27 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.
28 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.
29 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.
30 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.
31 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.
32 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.
33 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.
34 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.
35 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.
36 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.
37 20886705007681 222220 222220 TACIT ANCHOR With Double Ended Threader Tab 2.0mm TACIT DEPUY MITEK, LLC
38 10888867042695 AR-8021-50 AR-8021-50 2.8MM FAST TAK, ECONOMY PACK Arthrex® ARTHREX, INC.
39 10888867042688 AR-8021-25 AR-8021-25 2.8MM FASTAK ECONOMY PACK (25) Arthrex® ARTHREX, INC.
40 10888867042671 AR-8021-100 AR-8021-100 2.8MM FASTAK ECONOMY PACK (100) Arthrex® ARTHREX, INC.
41 10888867042640 AR-8020-50 AR-8020-50 5MM CORKSCREW, ECONOMY PACK Arthrex® ARTHREX, INC.
42 10888867042633 AR-8020-25 AR-8020-25 5MM CORKSCREW ECONOMY PACK (25) Arthrex® ARTHREX, INC.
43 10888867042626 AR-8020-100 AR-8020-100 5MM CORKSCREW ECONOMY PACK (100) Arthrex® ARTHREX, INC.
44 10886982179722 282.82 28282 BONE STAPLE 24MM X 25MM NA SYNTHES GMBH
45 10886982179715 282.80 28280 BONE STAPLE 20MM X 23MM NA SYNTHES GMBH
46 10886705010219 228320 228320 RAPIDLOC MENISCAL REPAIR-PLA TOPHAT / 0 Degrees Absorbable - PLA/PLA with Size 2 RAPIDLOC MENISCAL REPAIR-PLA TOPHAT / 0 Degrees Absorbable - PLA/PLA with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and straight needle RAPIDLOC PANACRYL DEPUY MITEK, LLC
47 10886705010202 228312 228312 RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 27 Degrees Absorbable - PLA/PDS with Size RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 27 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and 27 Degrees curved needle RAPIDLOC PDS PANACRYL DEPUY MITEK, LLC
48 10886705010196 228311 228311 RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 12 Degrees Absorbable - PLA/PDS with Size RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 12 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and 12 Degrees curved needle RAPIDLOC PDS PANACRYL DEPUY MITEK, LLC
49 10886705010189 228310 228310 RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 0 Degrees Absorbable - PLA/PDS with Size 2 RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 0 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and straight needle RAPIDLOC PDS PANACRYL DEPUY MITEK, LLC
50 10886705008629 222984 222984 Super QUICKANCHOR Plus DS With two Number 2 (5 metric) ORTHOCORD Braided Composi Super QUICKANCHOR Plus DS With two Number 2 (5 metric) ORTHOCORD Braided Composite Sutures, 36 Inches (91cm), Violet and Blue, each armed with 2 CP-2 needles. QUICKANCHOR ORTHOCORD DEPUY MITEK, LLC