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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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Excella 3™ - M711E3N75600

Ti 6Al 4V (ELI)
Innovasis, Inc.
E3N7560
In Commercial Distribution

  • M711E3N75600 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 60 Millimeter
E3N7560

  • Spinal bone screw, non-bioabsorbable

Excella 3™ - M711E3N65600

Ti 6Al 4V (ELI)
Innovasis, Inc.
E3N6560
In Commercial Distribution

  • M711E3N65600 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 60 Millimeter
E3N6560

  • Spinal bone screw, non-bioabsorbable

Biopor® - UCS90640

Large Square Chin
CEREMED, INC.
UCS-9064
In Commercial Distribution

  • UCS90640 ()

  • Length: 60 Millimeter
UCS-9064

  • Polyethylene craniofacial tissue reconstructive material

Biopor® - UCS60640

Medium Square Chin
CEREMED, INC.
UCS-6064
In Commercial Distribution

  • UCS60640 ()

  • Length: 60 Millimeter
UCS-6064

  • Polyethylene craniofacial tissue reconstructive material

Biopor® - UCS40640

Small Square Chin
CEREMED, INC.
UCS-4064
In Commercial Distribution

  • UCS40640 ()

  • Length: 60 Millimeter
UCS-4064

  • Polyethylene craniofacial tissue reconstructive material

Biopor® - UCR90640

Large Round Chin
CEREMED, INC.
UCR-9064
In Commercial Distribution

  • UCR90640 ()

  • Length: 60 Millimeter
UCR-9064

  • Polyethylene craniofacial tissue reconstructive material

Biopor® - UCR60640

Medium Round Chin
CEREMED, INC.
UCR-6064
In Commercial Distribution

  • UCR60640 ()

  • Length: 60 Millimeter
UCR-6064

  • Polyethylene craniofacial tissue reconstructive material

Biopor® - UCR40640

Small Round Chin
CEREMED, INC.
UCR-4064
In Commercial Distribution

  • UCR40640 ()

  • Length: 60 Millimeter
UCR-4064

  • Polyethylene craniofacial tissue reconstructive material

Super Staple™ Classic - M963173010

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)
METRIC MEDICAL DEVICES, INC.
17301
In Commercial Distribution

  • M963173010 ()

  • 18x18x15-2.0mm
  • Width: 18 Millimeter
  • Depth: 18 Millimeter
  • Depth: 15 Millimeter
17301

  • Orthopaedic bone staple, non-adjustable

X90 Pedicle Screw System - M697N600009151

Pre-Bent Rod 60 MM
Xtant Medical Holdings, Inc.
N60000915
In Commercial Distribution

  • M697N600009151 ()

  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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