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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 - 00846468089436

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-575-FX-35
Not in Commercial Distribution


  • 5.75mm (D) X 35mm (L)
10-575-FX-35

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

Quantum Spinal Fixation System - 00846468089429

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-575-FX-30
Not in Commercial Distribution


  • 5.75mm (D) X 30mm (L)
10-575-FX-30

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

Quantum Spinal Fixation System - 00846468089412

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-575-FX-25
Not in Commercial Distribution


  • 5.75mm (D) X 25mm (L)
10-575-FX-25

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

Quantum Spinal Fixation System - 00846468089399

X-LINK, VARIABLE
Pioneer Surgical Technology, Inc.
10-5060-VXL
Not in Commercial Distribution


  • 50mm - 60mm
10-5060-VXL

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

Quantum Spinal Fixation System - 00846468089382

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-500-PA-45
Not in Commercial Distribution


  • 5.00mm (D) X 45mm (L)
10-500-PA-45

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

Quantum Spinal Fixation System - 00846468089375

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-500-PA-40
Not in Commercial Distribution


  • 5.00mm (D) X 40mm (L)
10-500-PA-40

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

Quantum Spinal Fixation System - 00846468089368

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-475-PA-50
Not in Commercial Distribution


  • 4.75mm (D) X 50mm (L)
10-475-PA-50

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

Quantum Spinal Fixation System - 00846468089344

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-475-PA-40
Not in Commercial Distribution


  • 4.75mm (D) X 40mm (L)
10-475-PA-40

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

Quantum Spinal Fixation System - 00846468089337

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-475-PA-35
Not in Commercial Distribution


  • 4.75mm (D) X 35mm (L)
10-475-PA-35

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

Quantum Spinal Fixation System - 00846468089313

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-475-PA-25
Not in Commercial Distribution


  • 4.75mm (D) X 25mm (L)
10-475-PA-25

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

Quantum Spinal Fixation System - 00846468089290

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-475-FX-35
Not in Commercial Distribution


  • 4.75mm (D) X 35mm (L)
10-475-FX-35

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

Quantum Spinal Fixation System - 00846468089283

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-475-FX-30
Not in Commercial Distribution


  • 4.75mm (D) X 30mm (L)
10-475-FX-30

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

Quantum Spinal Fixation System - 00846468089276

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-475-FX-25
Not in Commercial Distribution


  • 4.75mm (D) X 25mm (L)
10-475-FX-25

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

Quantum Spinal Fixation System - 00846468089245

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-400-PA-45
Not in Commercial Distribution


  • 4.00mm (D) X 45mm (L)
10-400-PA-45

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

Quantum Spinal Fixation System - 00846468089221

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-400-PA-35
Not in Commercial Distribution


  • 4.00mm (D) X 35mm (L)
10-400-PA-35

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

Quantum Spinal Fixation System - 00846468089207

PEDICLE SCREW, POLYAXIAL
Pioneer Surgical Technology, Inc.
10-400-PA-25
Not in Commercial Distribution


  • 4.00mm (D) X 25mm (L)
10-400-PA-25

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

Quantum Spinal Fixation System - 00846468089184

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-50
Not in Commercial Distribution


  • 4.00mm (D) X 50mm (L)
10-400-FX-50

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

Quantum Spinal Fixation System - 00846468089160

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-40
Not in Commercial Distribution


  • 4.00mm (D) X 40mm (L)
10-400-FX-40

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

Quantum Spinal Fixation System - 00846468089146

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-30
Not in Commercial Distribution


  • 4.00mm (D) X 30mm (L)
10-400-FX-30

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

Quantum Spinal Fixation System - 00846468089122

PEDICLE SCREW, FIXED
Pioneer Surgical Technology, Inc.
10-400-FX-20
Not in Commercial Distribution


  • 4.00mm (D) X 20mm (L)
10-400-FX-20

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

Quantum Spinal Fixation System - 00846468089108

X-LINK, VARIABLE
Pioneer Surgical Technology, Inc.
10-3040-VXL
Not in Commercial Distribution


  • 30mm - 40mm
10-3040-VXL

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

Quantum Spinal Fixation System - 00846468089061

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-22-FXL
Not in Commercial Distribution


  • 22mm
10-22-FXL

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

Quantum Spinal Fixation System - 00846468089047

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-18-FXL
Not in Commercial Distribution


  • 18mm
10-18-FXL

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

Quantum Spinal Fixation System - 00846468089023

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-16-FXL
Not in Commercial Distribution


  • 16mm
10-16-FXL

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

Quantum Spinal Fixation System - 00846468089009

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-14-FXL
Not in Commercial Distribution


  • 14mm
10-14-FXL

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

Quantum Spinal Fixation System - 00846468088989

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-12-FXL
Not in Commercial Distribution


  • 12mm
10-12-FXL

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

Quantum Spinal Fixation System - 00846468001988

ELEVATOR, PEDICLE
Pioneer Surgical Technology, Inc.
10-ELEVATOR-P
Not in Commercial Distribution

10-ELEVATOR-P

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468000165

QSRS, PEDICLE SCREW INSRTR, HUSDON DRIVE
Pioneer Surgical Technology, Inc.
724-980
Not in Commercial Distribution

  • 00846468000165 ()
724-980

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Quantum Spinal Fixation System - 00846468002671

YOKE FORK
Pioneer Surgical Technology, Inc.
10-YOKEFORK
Not in Commercial Distribution

10-YOKEFORK

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002664

X-LINK HOLDER
Pioneer Surgical Technology, Inc.
10-XLNKHOLDER
Not in Commercial Distribution

10-XLNKHOLDER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002657

X-LINK BENDER, PERPENDICULAR
Pioneer Surgical Technology, Inc.
10-XLNKBNDRPER
Not in Commercial Distribution

10-XLNKBNDRPER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002640

X-LINK BENDER, PARALLEL
Pioneer Surgical Technology, Inc.
10-XLNKBNDRPAR
Not in Commercial Distribution

10-XLNKBNDRPAR

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002633

WRENCH, X-LINK
Pioneer Surgical Technology, Inc.
10-XLINKWRENCH
Not in Commercial Distribution

10-XLINKWRENCH

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002626

X-LINK GAGE
Pioneer Surgical Technology, Inc.
10-XLINKGAGE
Not in Commercial Distribution

10-XLINKGAGE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002619

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

10-XLINKDRIVER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002602

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

10-XLCASE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002596

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

10-VXLG-6080

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002589

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

10-VXLG-4060

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002572

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

10-VXLG-3040

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002565

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

10-VXLCADDY

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002558

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

10-TAPSLEEVE

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002541

TAP, 7.25mm, EXTENDED LENGTH
Pioneer Surgical Technology, Inc.
10-TAP-725-E
Not in Commercial Distribution

10-TAP-725-E

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002534

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

10-TAP-725-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002527

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

10-TAP-725

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002510

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

10-TAP-625-E

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002503

TAP, 6.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-625-1
Not in Commercial Distribution

10-TAP-625-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002497

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

10-TAP-625

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002480

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

10-TAP-525-E

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002473

TAP, 5.25mm, 1" THREAD
Pioneer Surgical Technology, Inc.
10-TAP-525-1
Not in Commercial Distribution

10-TAP-525-1

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002466

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

10-TAP-525

  • General internal orthopaedic fixation system implantation kit
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