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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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Quantum Spinal Fixation System - 00846468002039

GAGE, FIXED X-LINK
Pioneer Surgical Technology, Inc.
10-FXLGAGE
Not in Commercial Distribution

10-FXLGAGE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002015

CADDY, FIXED SCREW
Pioneer Surgical Technology, Inc.
10-FXCADDY-400
Not in Commercial Distribution


  • 4.00mm
10-FXCADDY-400

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001995

FINAL DRIVER
Pioneer Surgical Technology, Inc.
10-FINALDRIVER
Not in Commercial Distribution

10-FINALDRIVER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001971

ELEVATOR, LAMINA
Pioneer Surgical Technology, Inc.
10-ELEVATOR-L
Not in Commercial Distribution

10-ELEVATOR-L

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468016555

SHORT, INLINE HANDLE, HUDSON
Pioneer Surgical Technology, Inc.
32-HANDLE-S
Not in Commercial Distribution

32-HANDLE-S

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468016548

DETACHABLE TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-DTRL17-32
Not in Commercial Distribution

32-DTRL17-32

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468016531

DETACHABLE TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-DTRL17-26-6L
Not in Commercial Distribution

32-DTRL17-26-6L

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468016524

DETACHABLE TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-DTRL17-26
Not in Commercial Distribution

32-DTRL17-26

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468016517

DETACHABLE TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-DTRL16-32
Not in Commercial Distribution

32-DTRL16-32

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468016500

DETACHABLE TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-DTRL16-26-6L
Not in Commercial Distribution

32-DTRL16-26-6L

  • General internal orthopaedic fixation system implantation kit
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