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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 - 00846468089153

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


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

  • 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 - 00846468089139

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


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

  • 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 - 00846468089115

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-30-FXL
Not in Commercial Distribution


  • 30mm
10-30-FXL

  • 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 - 00846468089092

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-28-FXL
Not in Commercial Distribution


  • 28mm
10-28-FXL

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

Quantum Spinal Fixation System - 00846468089085

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-26-FXL
Not in Commercial Distribution


  • 26mm
10-26-FXL

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

Quantum Spinal Fixation System - 00846468089078

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-24-FXL
Not in Commercial Distribution


  • 24mm
10-24-FXL

  • 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 - 00846468089054

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-20-FXL
Not in Commercial Distribution


  • 20mm
10-20-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 - 00846468089030

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-17-FXL
Not in Commercial Distribution


  • 17mm
10-17-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 - 00846468089016

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-15-FXL
Not in Commercial Distribution


  • 15mm
10-15-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 - 00846468088996

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-13-FXL
Not in Commercial Distribution


  • 13mm
10-13-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 - 00846468088972

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-11-FXL
Not in Commercial Distribution


  • 11mm
10-11-FXL

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

Quantum Spinal Fixation System - 00846468090487

PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5001060-R
Not in Commercial Distribution

  • 00846468090487 ()

  • 5.5mm X 500mm X 10mm X 60mm
10-PJC5001060-R

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

Quantum Spinal Fixation System - 00846468090470

PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5001060-L
Not in Commercial Distribution

  • 00846468090470 ()

  • 5.5mm X 500mm X 10mm X 60mm
10-PJC5001060-L

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

Quantum Spinal Fixation System - 00846468090463

PRE CONTOURED, J-ROD, RIGHT
Pioneer Surgical Technology, Inc.
10-PJC5001050-R
Not in Commercial Distribution

  • 00846468090463 ()

  • 5.5mm X 500mm X 10mm X 50mm
10-PJC5001050-R

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

Quantum Spinal Fixation System - 00846468090456

PRE CONTOURED, J-ROD, LEFT
Pioneer Surgical Technology, Inc.
10-PJC5001050-L
Not in Commercial Distribution

  • 00846468090456 ()

  • 5.5mm X 500mm X 10mm X 50mm
10-PJC5001050-L

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

Quantum Spinal Fixation System - 00846468090449

WASHER
Pioneer Surgical Technology, Inc.
10-WASHER-5
Not in Commercial Distribution

  • 00846468090449 ()

  • 8mm (D), 5mm (H)
10-WASHER-5

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Quantum Spinal Fixation System - 00846468090432

WASHER
Pioneer Surgical Technology, Inc.
10-WASHER-3
Not in Commercial Distribution

  • 00846468090432 ()

  • 8mm (D), 3mm (H)
10-WASHER-3

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Quantum Spinal Fixation System - 00846468090425

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

10-TLH-S

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

Quantum Spinal Fixation System - 00846468090418

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

10-TLH-L

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

Quantum Spinal Fixation System - 00846468090401

THORACIC LAMINAR HOOK, ANGLED, RIGHT
Pioneer Surgical Technology, Inc.
10-TLHA-R
Not in Commercial Distribution

10-TLHA-R

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

Quantum Spinal Fixation System - 00846468090395

THORACIC LAMINAR HOOK, ANGLED, LEFT
Pioneer Surgical Technology, Inc.
10-TLHA-L
Not in Commercial Distribution

10-TLHA-L

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

Quantum Spinal Fixation System - 00846468090388

SPACER
Pioneer Surgical Technology, Inc.
10-SPACER-6
Not in Commercial Distribution

  • 00846468090388 ()

  • 8mm (D), 6mm (H)
10-SPACER-6

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Quantum Spinal Fixation System - 00846468090371

SPACER
Pioneer Surgical Technology, Inc.
10-SPACER-4
Not in Commercial Distribution

  • 00846468090371 ()

  • 8mm (D), 4mm (H)
10-SPACER-4

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Quantum Spinal Fixation System - 00846468090357

ROD CONNECTOR, PARALLEL, MULTI
Pioneer Surgical Technology, Inc.
10-RCPM
Not in Commercial Distribution


  • 5.5mm X 6.35mm
10-RCPM

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

Quantum Spinal Fixation System - 00846468090340

ROD CONNECTOR, PARALLEL
Pioneer Surgical Technology, Inc.
10-RCP
Not in Commercial Distribution

10-RCP

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

Quantum Spinal Fixation System - 00846468090333

ROD CONNECTOR, END TO END, MULTI
Pioneer Surgical Technology, Inc.
10-RCEM
Not in Commercial Distribution


  • 5.5mm X 6.35mm
10-RCEM

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

Quantum Spinal Fixation System - 00846468090326

ROD CONNECTOR, END TO END
Pioneer Surgical Technology, Inc.
10-RCE
Not in Commercial Distribution

10-RCE

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

Quantum Spinal Fixation System - 00846468090319

PEDICLE HOOK, SMALL
Pioneer Surgical Technology, Inc.
10-PH-S
Not in Commercial Distribution

10-PH-S

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

Quantum Spinal Fixation System - 00846468090302

PEDICLE HOOK, MEDIUM
Pioneer Surgical Technology, Inc.
10-PH-M
Not in Commercial Distribution

10-PH-M

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

Quantum Spinal Fixation System - 00846468090296

PEDICLE HOOK, LARGE
Pioneer Surgical Technology, Inc.
10-PH-L
Not in Commercial Distribution

10-PH-L

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

Quantum Spinal Fixation System - 00846468090289

LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-LOC-60
Not in Commercial Distribution

  • 00846468090289 ()

  • 60mm
10-LOC-60

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

Quantum Spinal Fixation System - 00846468090272

LATERAL OFFSET CONNECTOR
Pioneer Surgical Technology, Inc.
10-LOC-40
Not in Commercial Distribution


  • 40mm
10-LOC-40

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