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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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Yellowstone - B587A12283080

12mm H x 28mm W x 30mm L x 8 degrees
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A12283080 ()

  • Width: 28 Millimeter
  • Length: 30 Millimeter
  • Height: 12 Millimeter
  • Angle: 8 degree
A122830-8

  • Polymeric spinal interbody fusion cage

Yellowstone - B587X14164080

14mm H x 16mm x 40mm L x 8 degrees XLIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587X14164080 ()

  • Width: 16 Millimeter
  • Length: 40 Millimeter
  • Height: 14 Millimeter
  • Angle: 8 degree
X141640-8

  • Polymeric spinal interbody fusion cage

Yellowstone - B587TL141430120

14mm H x 14mm W x 30mm L x 12 degrees
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587TL141430120 ()

  • Width: 14 Millimeter
  • Length: 30 Millimeter
  • Height: 14 Millimeter
  • Angle: 12 degree
TL141430-12

  • Spinal implant trial

N/A - 00817438020742

85.0 MM X 25.0 MM X 1.29 MM X OSCILLATING BLADE
Omega Surgical Instruments Inc
DS-87516
In Commercial Distribution

  • 00817438020742 ()


  • Surgical saw blade, oscillating, single-use

General Instruments - 00840180516300

CERVICAL RASP, DOUBLE SIDED, 9 X 14 X 12 X 7°
ALPHATEC SPINE, INC.
CI-11254-20-09141207
In Commercial Distribution

  • 00840180516300 ()


  • Bone file/rasp, manual, reusable

General Instruments - 00840180516294

CERVICAL RASP, DOUBLE SIDED, 8 X 14 X 12 X 7°
ALPHATEC SPINE, INC.
CI-11254-20-08141207
In Commercial Distribution

  • 00840180516294 ()


  • Bone file/rasp, manual, reusable

General Instruments - 00840180516270

CERVICAL RASP, DOUBLE SIDED, 6 X 14 X 12 X 7°
ALPHATEC SPINE, INC.
CI-11254-20-06141207
In Commercial Distribution

  • 00840180516270 ()


  • Bone file/rasp, manual, reusable

Omni-Tract® - 10381780272946

Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75°
INTEGRA LIFESCIENCES CORPORATION
3086P
Not in Commercial Distribution

  • M2483086P1 ()
  • 10381780272946 ()
3086P

  • Surgical retraction system, reusable

AURORA SPINE - B521C190110160

VOX, TRIAL-L, HUDSON, 60mm x 18mm x 8 degrees x 16mm
AURORA SPINE, INC.
VOX
In Commercial Distribution

  • B521C190110160 ()

  • Height: 16 Millimeter
  • Angle: 8 degree
  • Width: 18 Millimeter
  • Length: 60 Millimeter
C19-011-016

  • Polymeric spinal fusion cage, sterile

AURORA SPINE - B521C190110150

VOX, TRIAL-L, HUDSON, 60mm x 18mm x 8 degrees x 15mm
AURORA SPINE, INC.
VOX
In Commercial Distribution

  • B521C190110150 ()

  • Height: 15 Millimeter
  • Angle: 8 degree
  • Width: 18 Millimeter
  • Length: 60 Millimeter
C19-011-015

  • Polymeric spinal fusion cage, sterile
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