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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 - 00846468002329

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

10-ROCKER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002299

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

10-PERSUADER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002275

CADDY, SCREW, POLYAXIAL 6.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-675
Not in Commercial Distribution

10-PACADDY-675

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002251

CADDY, SCREW, POLYAXIAL 4.75mm
Pioneer Surgical Technology, Inc.
10-PACADDY-475
Not in Commercial Distribution

10-PACADDY-475

  • General internal orthopaedic fixation system implantation kit

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
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