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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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INSTRUMENT CASE, LUMBAR, PRIMARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-P
Not in Commercial Distribution

10-INSTCASE-P

  • General internal orthopaedic fixation system implantation kit
INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
10-INSTCASE
Not in Commercial Distribution

10-INSTCASE

  • General internal orthopaedic fixation system implantation kit
IN-SITU ROD BENDER, RIGHT
Pioneer Surgical Technology, Inc.
10-INSITUBEND-R
Not in Commercial Distribution

10-INSITUBEND-R

  • General internal orthopaedic fixation system implantation kit
SCREW INSERTER
Pioneer Surgical Technology, Inc.
10-INSERTER
Not in Commercial Distribution

10-INSERTER

  • General internal orthopaedic fixation system implantation kit
IMPLANT CASE, LUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE
Not in Commercial Distribution

10-IMPCASE

  • General internal orthopaedic fixation system implantation kit
HOOK HOLDER, ANGLED
Pioneer Surgical Technology, Inc.
10-HOOKHOLDER-A
Not in Commercial Distribution

10-HOOKHOLDER-A

  • General internal orthopaedic fixation system implantation kit
DRIVER 8350517 T25 SET SCRW SWZZLE STICK
MEDTRONIC SOFAMOR DANEK, INC.
8350517
In Commercial Distribution

  • 00613994445148 ()


  • General internal orthopaedic fixation system implantation kit
CONTACT ALP, THREADED SCREW INSERTER
Pioneer Surgical Technology, Inc.
725-017
Not in Commercial Distribution

  • 00846468000547 ()
725-017

  • General internal orthopaedic fixation system implantation kit
MIS FUS, 7mm PADDLE DISTRACTOR, 3.3" OAL
Pioneer Surgical Technology, Inc.
724-994
Not in Commercial Distribution

  • 00846468000394 ()

  • 7mm (Width)
724-994

  • General internal orthopaedic fixation system implantation kit
STREAMLINE TL, DISTRACTOR, STRAIGHT TIP
Xtant Medical Holdings, Inc.
724-987
Not in Commercial Distribution

  • 00846468000103 ()
724-987

  • General internal orthopaedic fixation system implantation kit
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