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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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Cortera Spinal Fixation System - 00840311252732

Caddy, IMP, CC Cann, 4.5
Xtant Medical Holdings, Inc.
1509-230070
In Commercial Distribution

  • 00840311252732 ()


  • Instrument tray, reusable

Cortera Spinal Fixation System - 00840311247134

Case, Full, Cann, CC, IMP
Xtant Medical Holdings, Inc.
1509-010090
In Commercial Distribution

  • 00840311247134 ()


  • Instrument tray, reusable

General Instruments - 00840180537251

INSIGNIA CC DS GUIDE, SP
ALPHATEC SPINE, INC.
CI-11783-CC15
In Commercial Distribution

  • 00840180537251 ()


  • Surgical drill guide, reusable

General Instruments - 00840180536407

INSIGNIA CC VA DS GUIDE
ALPHATEC SPINE, INC.
CI-11753-CC
In Commercial Distribution

  • 00840180536407 ()


  • Surgical drill guide, reusable

General Instrument - 00840180511718

Modular OCT Screw Tip, CC
ALPHATEC SPINE, INC.
CI-11087-CC
In Commercial Distribution

  • 00840180511718 ()


  • Surgical implant handling forceps

AoN Implants - 00840192701565

2 pieces Transfer - Short - CC
FAICO MEDICAL LLC
ATR00SHOSN00C
Not in Commercial Distribution

  • 00840192701565 ()


  • Dental implant system

AoN Implants - 00840192701558

2 pieces Transfer - Long - CC
FAICO MEDICAL LLC
ATR00LNGSN00C
Not in Commercial Distribution

  • 00840192701558 ()


  • Dental implant system

AoN Implants - 00840192701527

Transfer - h.9 mm. - CC
FAICO MEDICAL LLC
ATR00SHOIP00C
Not in Commercial Distribution

  • 00840192701527 ()


  • Dental implant system

AoN Implants - 00840192701510

Transfer - h.12 mm. - CC
FAICO MEDICAL LLC
ATR00000IP00C
Not in Commercial Distribution

  • 00840192701510 ()


  • Dental implant system

Sigma - 00190376316604

120mm C-C Blade, Sigma TLIF
ALPHATEC SPINE, INC.
269-150-120
In Commercial Distribution

  • 00190376316604 ()


  • Surgical retraction system, reusable
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