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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OSStaple - 00810633020654

OSStaple 20X20W2
Biomedical Enterprises, Inc.
OS-2020W2
In Commercial Distribution

  • 00810633020654 ()

  • Width: 20 Millimeter
  • Length: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable

OSStaple - 00810633020586

OSStaple 20X20 W2X3
Biomedical Enterprises, Inc.
OS-2020W2X3
In Commercial Distribution

  • 00810633020586 ()

  • Length: 20 Millimeter
  • Width: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable

OSStaple - 00810633020395

Step OSStaple 20X20X20 W2X3
Biomedical Enterprises, Inc.
OS-2020W2X3
In Commercial Distribution

  • 00810633020395 ()

  • Width: 20 Millimeter
  • Length: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable

Speed - 00810633020227

SPEED 20X20X20mm implant
Biomedical Enterprises, Inc.
SE-2020
In Commercial Distribution

  • 00810633020227 ()

  • Length: 20 Millimeter
  • Width: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable

Super Staple™ Classic - M963175010

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)
METRIC MEDICAL DEVICES, INC.
17501
In Commercial Distribution

  • M963175010 ()

  • 20x20x20-2x3mm
  • Depth: 20 Millimeter
  • Width: 20 Millimeter
17501

  • Orthopaedic bone staple, non-adjustable

Super Staple™ Classic - M963174010

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

Vertex - 00810005665162

Implant is 20mm bridge staple, 20mm x 20mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-20-20-20
In Commercial Distribution

  • 00810005665162 ()

  • Length: 20 Millimeter
  • Depth: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable

Strattice Reconstructive Tissue Matrix Laparoscopic - M32820200050

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

BIOFOAM - 00840420135681

No Description
WRIGHT MEDICAL TECHNOLOGY, INC.
46S42008
Not in Commercial Distribution

  • 00840420135681 ()

  • Length: 20 Millimeter
  • Width: 20 Millimeter
46S42008

  • Metallic osteotomy fusion cage, non-customized

United Hip System - 04719872140740

U-Motion II XPE Cup Liner, 20 Degrees, ID40mm, OD54mm
UNITED ORTHOPEDIC CORP.
1406-5055
In Commercial Distribution

  • 04719872140740 ()


  • Metal-on-polyethylene total hip prosthesis
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