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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 - 00846468022198

THORACIC LAMINAR HOOK, ANGLED, RIGHT
Pioneer Surgical Technology, Inc.
10-TLHA-R
Not in Commercial Distribution

  • 00846468022198 ()
10-TLHA-R

  • Bone-screw internal spinal fixation system, non-sterile

Quantum® Spinal Fixation System - 00846468022181

DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468022174

THORACIC LAMINAR HOOK, ANGLED, LEFT
Pioneer Surgical Technology, Inc.
10-TLHA-L
Not in Commercial Distribution

  • 00846468022174 ()
10-TLHA-L

  • Bone-screw internal spinal fixation system, non-sterile

Quantum® Spinal Fixation System - 00846468022150

T-HANDLE
Pioneer Surgical Technology, Inc.
10-THANDLE
Not in Commercial Distribution

  • 00846468022150 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022143

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-600
Not in Commercial Distribution

  • 00846468022143 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021795

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

  • 00846468021795 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021788

RATCHETING STRAIGHT HANDLE, 1/4" SDQC
Pioneer Surgical Technology, Inc.
10-RSHANDLE
Not in Commercial Distribution

  • 00846468021788 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021771

COUNTER TORQUE WRENCH
Pioneer Surgical Technology, Inc.
10-RR-HANDLE
Not in Commercial Distribution

  • 00846468021771 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021764

RATCHETING PALM HANDLE, 1/4" SDQC
Pioneer Surgical Technology, Inc.
10-RPHANDLE
Not in Commercial Distribution

  • 00846468021764 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021535

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

  • 00846468021535 ()


  • General internal orthopaedic fixation system implantation kit
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