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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
Lateral Guide, Closing Wedge Osteotomy, 20mm x 14mm
Mios Marketing, LLC
Equinox
In Commercial Distribution
- G2710460200140 ()
- Length: 20 Millimeter
- Depth: 20 Millimeter
04-6020-014
- Orthopaedic implant aiming/guiding block, single-use
Lateral Malleolar Osteotomy Guide, 20mm x 20mm
Mios Marketing, LLC
PEAK Solo
In Commercial Distribution
- G2710440200200 ()
- Length: 20 Millimeter
- Depth: 20 Millimeter
04-4020-020
- Orthopaedic implant aiming/guiding block, single-use
Talar Osteotmy Guide, 20mm x 20mm
Mios Marketing, LLC
Intellifuse
In Commercial Distribution
- G2710310200200 ()
- Length: 20 Millimeter
- Depth: 20 Millimeter
03-1020-020
- Orthopaedic implant aiming/guiding block, single-use
No Description
OT MEDICAL, LLC
400-3723
In Commercial Distribution
- B04140037230 ()
- Width: 20 Millimeter
- Length: 20 Millimeter
400-3723
- Orthopaedic bone staple, non-adjustable
Strattice Laparoscopic 20cm x 20cm
LIFECELL CORPORATION
2020005
In Commercial Distribution
- M32820200050 ()
- 00818410012908 ()
- Width: 20 Centimeter
- Length: 20 Centimeter
2020005
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Water-based Personal Lubricant
CC Wellness LLC
41022
- Sexual lubricant
Water-based Personal Lubricant
CC Wellness LLC
41020
In Commercial Distribution
- B362410201 ()
- B362410200 ()
- Sexual lubricant
Water-based Personal Lubricant
CC Wellness LLC
40385
In Commercial Distribution
- B362403851 ()
- B362403850 ()
- Sexual lubricant
Water-based Personal Lubricant
CC Wellness LLC
40384
In Commercial Distribution
- B362403841 ()
- B362403840 ()
- Sexual lubricant