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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 - 00846468022211

THORACIC LAMINAR HOOK, SMALL
Pioneer Surgical Technology, Inc.
10-TLH-S
Not in Commercial Distribution

  • 00846468022211 ()
10-TLH-S

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

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 - 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 - 00846468022136

ROD TEMPLATE
Pioneer Surgical Technology, Inc.
10-TEMPLATE-400
Not in Commercial Distribution

  • 00846468022136 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022112

TAP SLEEVE
Pioneer Surgical Technology, Inc.
10-TAPSLEEVE
Not in Commercial Distribution

  • 00846468022112 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022099

TAP, 7.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-725-1
Not in Commercial Distribution

  • 00846468022099 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022075

TAP, 6.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-625-E
Not in Commercial Distribution

  • 00846468022075 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022044

TAP, 5.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-525-E
Not in Commercial Distribution

  • 00846468022044 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022020

TAP, 5.25mm
Pioneer Surgical Technology, Inc.
10-TAP-525
Not in Commercial Distribution

  • 00846468022020 ()


  • General internal orthopaedic fixation system implantation kit
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