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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 Class Implantable

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Reform Ti CT Modular MIS Pedicle Screw System - 00840019942232

Ø5.5mm Lordotic Rod Caddy
PRECISION SPINE, INC.
64-SC-0116
In Commercial Distribution

  • 00840019942232 ()
64-SC-0116

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

Reform Ti CT Modular MIS Pedicle Screw System - 00840019942225

Standard / Reduction Tulip Caddy
PRECISION SPINE, INC.
64-SC-0115
In Commercial Distribution

  • 00840019942225 ()
64-SC-0115

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

Reform Ti CT Modular MIS Pedicle Screw System - 00840019942201

Ø7.5 / 8.5mm Screw Caddy
PRECISION SPINE, INC.
64-SC-0113
In Commercial Distribution

  • 00840019942201 ()
64-SC-0113

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

Reform Ti CT Modular MIS Pedicle Screw System - 00840019942195

Ø5.5 / 6.5mm Screw Caddy
PRECISION SPINE, INC.
64-SC-0112
In Commercial Distribution

  • 00840019942195 ()
64-SC-0112

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

Reform Ti CT Modular MIS Pedicle Screw System - 00840019942188

Lock-Screw Caddy
PRECISION SPINE, INC.
64-SC-0111
In Commercial Distribution

  • 00840019942188 ()
64-SC-0111

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

Reform Ti CT Modular MIS Pedicle Screw System - 00840019942171

Implant Sterilization Case
PRECISION SPINE, INC.
64-SC-0100
In Commercial Distribution

  • 00840019942171 ()
64-SC-0100

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

Reform TI Pedicle Screw System - 00840019940603

Ø10.5 x 120mm Modular Bone Screw, Non-Fluted
PRECISION SPINE, INC.
39-SG-1012
In Commercial Distribution

  • 00840019940603 ()
39-SG-1012

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

Reform TI Pedicle Screw System - 00840019940597

Ø10.5 x 110mm Modular Bone Screw, Non-Fluted
PRECISION SPINE, INC.
39-SG-1011
In Commercial Distribution

  • 00840019940597 ()
39-SG-1011

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

Reform TI Pedicle Screw System - 00840019940566

Ø10.5 x 80mm Modular Bone Screw, Non-Fluted
PRECISION SPINE, INC.
39-SG-1080
In Commercial Distribution

  • 00840019940566 ()
39-SG-1080

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

Reform TI Pedicle Screw System - 00840019940528

Ø10.5 x 50mm Modular Bone Screw, Non-Fluted
PRECISION SPINE, INC.
39-SG-1050
In Commercial Distribution

  • 00840019940528 ()
39-SG-1050

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