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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 - 00840019961950

33X 27 X 13mm X 20° PEEK
PRECISION SPINE, INC.
69-AM-2013
In Commercial Distribution

  • 00840019961950 ()
69-AM-2013

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019961745

30X 26 X 19mm X 20° PEEK
PRECISION SPINE, INC.
69-AS-2019
In Commercial Distribution

  • 00840019961745 ()
69-AS-2019

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019961721

30X 26 X 15mm X 20° PEEK
PRECISION SPINE, INC.
69-AS-2015
In Commercial Distribution

  • 00840019961721 ()
69-AS-2015

  • Polymeric spinal interbody fusion cage

ACUMED - 10806378049675

2.3 mm x 20 mm Hexalobe MultiScrew
Acumed LLC
3004-23020-S
In Commercial Distribution

  • 10806378049675 ()


  • Orthopaedic bone screw (non-sliding)

ACUMED - 10806378049668

2.3 mm x 20 mm Hexalobe MultiScrew
Acumed LLC
3004-23020
In Commercial Distribution

  • 10806378049668 ()


  • Orthopaedic bone screw (non-sliding)

Dakota ALIF System - 00840019963664

39X 29 X 19mm X 20° PEEK-2C
PRECISION SPINE, INC.
69-AG-2019-2C
Not in Commercial Distribution

  • 00840019963664 ()
69-AG-2019-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963657

39X 29 X 17mm X 20° PEEK-2C
PRECISION SPINE, INC.
69-AG-2017-2C
Not in Commercial Distribution

  • 00840019963657 ()
69-AG-2017-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963640

39X 29 X 15mm X 20° PEEK-2C
PRECISION SPINE, INC.
69-AG-2015-2C
In Commercial Distribution

  • 00840019963640 ()
69-AG-2015-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963633

39X 29 X 13mm X 20° PEEK-2C
PRECISION SPINE, INC.
69-AG-2013-2C
Not in Commercial Distribution

  • 00840019963633 ()
69-AG-2013-2C

  • Polymeric spinal interbody fusion cage

Dakota ALIF System - 00840019963428

36X 28 X 19mm X 20° PEEK-2C
PRECISION SPINE, INC.
69-AL-2019-2C
Not in Commercial Distribution

  • 00840019963428 ()
69-AL-2019-2C

  • Polymeric spinal interbody fusion cage
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