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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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Sypher ALIF Spacer System - 00812593020002

Sypher Spacer - 28mm X 24mm X 12mm X 7°
Biogennix, LLC
SAS-28241207
In Commercial Distribution

  • 00812593020002 ()

  • Angle: 7 degree
  • Height: 12 Millimeter
  • Depth: 24 Millimeter
  • Width: 28 Millimeter
SAS-28241207

  • Polymeric spinal fusion cage, sterile

Reprocessed StableCut Oscillating Saw Blade - B39005025060SMF1

5.5 x 25 x 0.38mm
SURETEK MEDICAL
05025060SMF
In Commercial Distribution

  • B39005025060SMF1 ()


  • Surgical power tool system handpiece, sawing, line-powered

AlliedSil™ Sheeting - M724SL0617401

Silicone Sheeting Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 152.4 cm x 431.8mm x 1.016 mm
In Commercial Distribution

  • M724SL0617401 ()
SL0617-40

  • Silicone-sheet tissue reconstructive material, non-sterile

ECHO TiNano PLIF - B521108826100810

ECHO TiNano PLIF 26mm X 10mm X 8 X 10mm
AURORA SPINE, INC.
108026100810
Not in Commercial Distribution

  • B521108826100810 ()

  • Height: 10 Millimeter
  • Angle: 8 degree
  • Width: 10 Millimeter
  • Length: 26 Millimeter
108826100810

  • Polymeric spinal fusion cage, sterile

ECHO TiNano PLIF - B521108824080807

ECHO TiNano PLIF 24mm X 8mm X 8 X 7mm
AURORA SPINE, INC.
108024080807
Not in Commercial Distribution

  • B521108824080807 ()

  • Height: 7 Millimeter
  • Angle: 8 degree
  • Width: 8 Millimeter
  • Length: 24 Millimeter
108824080807

  • Polymeric spinal fusion cage, sterile

ECHO TiNano PLIF - B521108822080812

ECHO TiNano PLIF 22mm X 8mm X 8 X 12mm
AURORA SPINE, INC.
108022080812
Not in Commercial Distribution

  • B521108822080812 ()

  • Height: 12 Millimeter
  • Angle: 8 degree
  • Width: 8 Millimeter
  • Length: 22 Millimeter
108822080812

  • Polymeric spinal fusion cage, sterile

DISCOVERY TiNano ACIF - B521105010508

DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 8mm
AURORA SPINE, INC.
105010508
Not in Commercial Distribution

  • B521105010508 ()

  • Height: 8 Millimeter
  • Angle: 5 degree
  • Width: 16 Millimeter
  • Length: 14 Millimeter
105010508

  • Polymeric spinal fusion cage, sterile

DISCOVERY TiNano ACIF - B521105010505

DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 5mm
AURORA SPINE, INC.
105010505
Not in Commercial Distribution

  • B521105010505 ()

  • Height: 5 Millimeter
  • Angle: 5 degree
  • Width: 16 Millimeter
  • Length: 14 Millimeter
105010505

  • Polymeric spinal fusion cage, sterile

Aurora Spine - B5211063283808170

AFFINITY, TRIAL-L, 28mm x 38mm x 8 degrees x 17mm
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B5211063283808170 ()

  • Height: 17 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter
106-32838-0817

  • Polymeric spinal fusion cage, sterile

Aurora Spine - B5211063283808160

AFFINITY, TRIAL-L, 28mm x 38mm x 8 degrees x 16mm
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B5211063283808160 ()

  • Height: 16 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter
106-32838-0816

  • Polymeric spinal fusion cage, sterile
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