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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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Cross-Fuse PEEK IBF System - 00846468038991

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL14-15
Not in Commercial Distribution

35-DTRL14-15

  • Surgical implant template, reusable

CONTACT ALP Anterior Lumbar Plate System - 00846468032937

AUXILIARY PLATE AND SCREW CADDY
Pioneer Surgical Technology, Inc.
25-AUXCAD
Not in Commercial Distribution

25-AUXCAD

  • General internal orthopaedic fixation system implantation kit

CONTACT ALP Anterior Lumbar Plate System - 00846468032685

TEMPORARY HOLDING PIN, THREADED
Pioneer Surgical Technology, Inc.
25-THREADEDPIN
Not in Commercial Distribution

25-THREADEDPIN

  • General internal orthopaedic fixation system implantation kit

CONTACT ALP Anterior Lumbar Plate System - 00846468032661

T-HANDLE, RATCHETING
Pioneer Surgical Technology, Inc.
25-RTHANDLE
Not in Commercial Distribution

25-RTHANDLE

  • General internal orthopaedic fixation system implantation kit

Contact PEEK IBF System - 00846468032623

WINDOW INSERTER
Pioneer Surgical Technology, Inc.
34-WNDWTOOL-40
Not in Commercial Distribution

34-WNDWTOOL-40

  • Orthopaedic inorganic implant inserter/extractor, reusable

Contact PEEK IBF System - 00846468032609

WINDOW INSERTER
Pioneer Surgical Technology, Inc.
34-WNDWTOOL-36
Not in Commercial Distribution

34-WNDWTOOL-36

  • Orthopaedic inorganic implant inserter/extractor, reusable

Contact PEEK IBF System - 00846468032562

WINDOW INSERTER
Pioneer Surgical Technology, Inc.
34-WNDWTOOL-30
Not in Commercial Distribution

34-WNDWTOOL-30

  • Orthopaedic inorganic implant inserter/extractor, reusable

Contact PEEK IBF System - 00846468032548

DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW40-20
Not in Commercial Distribution

34-WINDOW40-20

  • General internal orthopaedic fixation system implantation kit

Contact PEEK IBF System - 00846468032524

DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW40-18
Not in Commercial Distribution

34-WINDOW40-18

  • General internal orthopaedic fixation system implantation kit

Contact PEEK IBF System - 00846468031473

DISTRACTION WINDOW
Pioneer Surgical Technology, Inc.
34-WINDOW40-14
Not in Commercial Distribution

34-WINDOW40-14

  • General internal orthopaedic fixation system implantation kit
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