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 Class Implantable

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MD-Max™ Triple Lead MIS Instrument Kit
PRECISION SPINE, INC.
43-8200-CA
In Commercial Distribution

  • 00840019936941 ()
43-8200-CA

  • Bone-screw internal spinal fixation system, non-sterile
MD-Max™ ULIF Retractor Instrument Kit
PRECISION SPINE, INC.
43-8000-CA
In Commercial Distribution

  • 00840019936927 ()
43-8000-CA

  • Bone-screw internal spinal fixation system, non-sterile
Tray and Implants (Complete)
PRECISION SPINE, INC.
48-2000-CA
In Commercial Distribution

  • 00840019936798 ()
48-2000-CA

  • Bone-screw internal spinal fixation system, non-sterile
Implant Case 1 (Complete)
PRECISION SPINE, INC.
63-8600-CA
In Commercial Distribution

  • 00840019936521 ()
63-8600-CA

  • Bone-screw internal spinal fixation system, non-sterile
T30 Lock-Screw
PRECISION SPINE, INC.
64-LS-0100
In Commercial Distribution

  • 00840019942768 ()
64-LS-0100

  • Bone-screw internal spinal fixation system, non-sterile
Modular MIS Base Tulip
PRECISION SPINE, INC.
64-MT-0401
In Commercial Distribution

  • 00840019942744 ()
64-MT-0401

  • Bone-screw internal spinal fixation system, non-sterile
Standard / Reduction Tulip Kit
PRECISION SPINE, INC.
64-BK-0115
In Commercial Distribution

  • 00840019942355 ()
64-BK-0115

  • Bone-screw internal spinal fixation system, non-sterile
  • Orthopaedic surgical procedure kit, non-medicated, reusable
Ø7.5 / 8.5mm Screw Kit
PRECISION SPINE, INC.
64-BK-0113
In Commercial Distribution

  • 00840019942331 ()
64-BK-0113

  • Orthopaedic surgical procedure kit, non-medicated, reusable
  • Bone-screw internal spinal fixation system, non-sterile
Lock-Screw Kit
PRECISION SPINE, INC.
64-BK-0111
In Commercial Distribution

  • 00840019942317 ()
64-BK-0111

  • Orthopaedic surgical procedure kit, non-medicated, reusable
  • Bone-screw internal spinal fixation system, non-sterile
Standard/Reduction/Extended Tab Tulip Implant Kit
PRECISION SPINE, INC.
64-BK-0103
In Commercial Distribution

  • 00840019942300 ()
64-BK-0103

  • Bone-screw internal spinal fixation system, non-sterile
  • Orthopaedic surgical procedure kit, non-medicated, reusable
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