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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 MIS Cannulated System - 00846468050535

Nerve Monitoring Cable
Pioneer Surgical Technology, Inc.
51-STIM-1
Not in Commercial Distribution

  • 00846468050535 ()
51-STIM-1

  • Nerve-function monitor

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 - 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 - 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 - 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 - 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 - 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 - 00846468002442

TAP, 4.25mm
Pioneer Surgical Technology, Inc.
10-TAP-425
Not in Commercial Distribution

10-TAP-425

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468002411

SCREW INSERTER
Pioneer Surgical Technology, Inc.
10-SCRWINSERT-S
Not in Commercial Distribution

10-SCRWINSERT-S

  • General internal orthopaedic fixation system implantation kit
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