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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 - 00846468002244

CADDY, SCREW, POLYAXIAL 4.00mm
Pioneer Surgical Technology, Inc.
10-PACADDY-400
Not in Commercial Distribution

10-PACADDY-400

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002237

CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-775
Not in Commercial Distribution


  • 7.75mm
10-PABCADDY-775

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002220

CADDY, ILIAC BOLT, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-PABCADDY-675
Not in Commercial Distribution


  • 6.75mm
10-PABCADDY-675

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002213

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

10-OSTEOTOME

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002206

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

10-MANIPULATOR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002190

ROD REDUCER, ANGLED
Pioneer Surgical Technology, Inc.
10-MANIPANGLED
Not in Commercial Distribution

10-MANIPANGLED

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002183

LOCKING TUBE
Pioneer Surgical Technology, Inc.
10-LOCKINGTUBE
Not in Commercial Distribution

10-LOCKINGTUBE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002176

CADDY, LOCKING CAP
Pioneer Surgical Technology, Inc.
10-LCAPCADDY
Not in Commercial Distribution

10-LCAPCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002169

INSTRUMENT CASE, THORACOLUMBAR
Pioneer Surgical Technology, Inc.
10-INSTCASE-TL
Not in Commercial Distribution

  • 00846468002169 ()
10-INSTCASE-TL

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002152

INSTRUMENT CASE, LUMBAR, SECONDARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-S
Not in Commercial Distribution

10-INSTCASE-S

  • General internal orthopaedic fixation system implantation kit
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