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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 - 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 - 00846468002008

FIXED, ILIAC BOLT CADDY
Pioneer Surgical Technology, Inc.
10-FXBCADDY-875
Not in Commercial Distribution


  • 8.75mm
10-FXBCADDY-875

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001988

ELEVATOR, PEDICLE
Pioneer Surgical Technology, Inc.
10-ELEVATOR-P
Not in Commercial Distribution

10-ELEVATOR-P

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001964

CLAW ROD PUSHER
Pioneer Surgical Technology, Inc.
10-CLAWPUSHER
Not in Commercial Distribution

10-CLAWPUSHER

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468022167

TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-TRIAL-9-26
Not in Commercial Distribution

32-TRIAL-9-26

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468021962

TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-TRIAL-9-22
Not in Commercial Distribution

32-TRIAL-9-22

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468021665

TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-TRIAL-8-26
Not in Commercial Distribution

32-TRIAL-8-26

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468021634

TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-TRIAL-17-26
Not in Commercial Distribution

32-TRIAL-17-26

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468020668

TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-TRIAL-15-22
Not in Commercial Distribution

32-TRIAL-15-22

  • General internal orthopaedic fixation system implantation kit

BULLET-TIP PEEK IBF SYSTEM - 00846468019723

TRIAL SPACER
Pioneer Surgical Technology, Inc.
32-TRIAL-12-26
Not in Commercial Distribution

32-TRIAL-12-26

  • General internal orthopaedic fixation system implantation kit
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