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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 - 00846468022297

DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022280

CASE, X-LINK™
Pioneer Surgical Technology, Inc.
10-XLCASE
Not in Commercial Distribution

  • 00846468022280 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022259

GAGE, X-LINK®, VARIABLE, 60mm-80mm
Pioneer Surgical Technology, Inc.
10-VXLG-6080
Not in Commercial Distribution

  • 00846468022259 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022242

GAGE, X-LINK®, VARIABLE, 40mm-60mm
Pioneer Surgical Technology, Inc.
10-VXLG-4060
Not in Commercial Distribution

  • 00846468022242 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022235

GAGE, X-LINK®, VARIABLE, 30mm-40mm
Pioneer Surgical Technology, Inc.
10-VXLG-3040
Not in Commercial Distribution

  • 00846468022235 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022228

CADDY, X-LINK™, VARIABLE
Pioneer Surgical Technology, Inc.
10-VXLCADDY
Not in Commercial Distribution

  • 00846468022228 ()


  • General internal orthopaedic fixation system implantation kit

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 - 00846468022204

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

  • 00846468022204 ()
10-TLH-L

  • 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 - 00846468022181

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

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit
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