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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; 2.4mm Pull Pins; 1ea 2.4mm Drill Bit (color band of red)
METRIC MEDICAL DEVICES, INC.
17401
In Commercial Distribution
- M963174010 ()
- 20x20x20-2.0mm
- Width: 20 Millimeter
- Depth: 20 Millimeter
17401
- Orthopaedic bone staple, non-adjustable
Macroporous Mesh, Monofilament Polypropylene
SOFRADIM PRODUCTION
PPM2020X3
In Commercial Distribution
- 20884521213842 ()
- 10884521213845 ()
- Length: 20 Centimeter
- Width: 20 Centimeter
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Macroporous Mesh, Monofilament Polypropylene
SOFRADIM PRODUCTION
PPM2020
In Commercial Distribution
- 10884521213777 ()
- Length: 20 Centimeter
- Width: 20 Centimeter
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Hydrophilic 3-Dimensional Mesh,Polyester
SOFRADIM PRODUCTION
TET2020
In Commercial Distribution
- 10884521180352 ()
- Width: 20 Centimeter
- Length: 20 Centimeter
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Hydrophilic 2-Dimensional Mesh,Polyester
SOFRADIM PRODUCTION
TEC2020
In Commercial Distribution
- 10884521180277 ()
- Length: 20 Centimeter
- Width: 20 Centimeter
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Lightweight Mesh,Monofilament Polyester
SOFRADIM PRODUCTION
TCM2020X3
Not in Commercial Distribution
- 20884521178905 ()
- 10884521178908 ()
- Width: 20 Centimeter
- Length: 20 Centimeter
TCM2020X3
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Lightweight Mesh Monofilament Polyester
SOFRADIM PRODUCTION
TCM2020
Not in Commercial Distribution
- 10884521178892 ()
- Length: 20 Centimeter
- Width: 20 Centimeter
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Hydrocolloid Dressing (Thin/Transparent)
Covalon Technologies Ltd
5202020
In Commercial Distribution
- 00825439016114 ()
- 00825439016107 ()
- Length: 20 Centimeter
- Width: 20 Centimeter
5202020
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Hydrocolloid Dressing
Covalon Technologies Ltd
5002020
In Commercial Distribution
- 00825439012031 ()
- 00825439012024 ()
- Length: 20 Centimeter
- Width: 20 Centimeter
5002020
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Self-Adherent Soft Silicone Foam Dressing
Covalon Technologies Ltd
1002020
In Commercial Distribution
- 00825439014738 ()
- 00825439014721 ()
- Length: 20 Centimeter
- Width: 20 Centimeter
- Exudate-absorbent dressing, non-gel, non-antimicrobial