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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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Dakota ALIF System - 00840019968058

Standalone Cage Implant & Trial Case (30, 33, & 36mm)
PRECISION SPINE, INC.
69-SC-0100
In Commercial Distribution

  • 00840019968058 ()
69-SC-0100

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967433

15° Implant Kit - 18mm & 22mm Widths
PRECISION SPINE, INC.
60-BK-8000
In Commercial Distribution

  • 00840019967433 ()
60-BK-8000

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967426

Implant Caddy - 24mm x 15° w/ 18mm H Kit
PRECISION SPINE, INC.
60-BK-7006
In Commercial Distribution

  • 00840019967426 ()
60-BK-7006

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967419

Implant Caddy - 24mm x 15° Kit
PRECISION SPINE, INC.
60-BK-7003
In Commercial Distribution

  • 00840019967419 ()
60-BK-7003

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967396

Implant Caddy - 22mm x 15° w/ 18mm H Kit
PRECISION SPINE, INC.
60-BK-7005
In Commercial Distribution

  • 00840019967396 ()
60-BK-7005

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967389

Implant Caddy - 22mm x 15° Kit
PRECISION SPINE, INC.
60-BK-7002
In Commercial Distribution

  • 00840019967389 ()
60-BK-7002

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967365

Implant Caddy - 18mm x 15° w/ 18mm H Kit
PRECISION SPINE, INC.
60-BK-7004
In Commercial Distribution

  • 00840019967365 ()
60-BK-7004

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967358

Implant Caddy - 18mm x 15° Kit
PRECISION SPINE, INC.
60-BK-7001
In Commercial Distribution

  • 00840019967358 ()
60-BK-7001

  • Polymeric spinal interbody fusion cage

MD-Vue™ Lateral Discectomy System - 00840019967334

Implant Caddy - 24mm x 7° Kit
PRECISION SPINE, INC.
60-BK-5003
In Commercial Distribution

  • 00840019967334 ()
60-BK-5003

  • Polymeric spinal interbody fusion cage

ShurFit® LLIF System - 00840019966917

24x60x18mm - 15° PEEK Cage
PRECISION SPINE, INC.
23-LC2460-18
In Commercial Distribution

  • 00840019966917 ()
23-LC2460-18

  • Polymeric spinal interbody fusion cage
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