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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 Pedicle Screw System - 00840019900546

ø9.5 x 100 mm POLYAXIAL SCREW
PRECISION SPINE, INC.
39-PA-9500
In Commercial Distribution

  • 00840019900546 ()
39-PA-9500

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

Reform Pedicle Screw System - 00840019900539

ø8.5 x 90 mm POLYAXIAL SCREW
PRECISION SPINE, INC.
39-PA-8590
In Commercial Distribution

  • 00840019900539 ()
39-PA-8590

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

Reform Pedicle Screw System - 00840019900522

8.5 x 80mm Polyaxial Screw
PRECISION SPINE, INC.
39-PA-8580
In Commercial Distribution

  • 00840019900522 ()
39-PA-8580

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

Reform Pedicle Screw System - 00840019900515

8.5 x 70mm Polyaxial Screw
PRECISION SPINE, INC.
39-PA-8570
In Commercial Distribution

  • 00840019900515 ()
39-PA-8570

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

Reform Pedicle Screw System - 00840019900508

8.5 x 60mm Polyaxial Screw
PRECISION SPINE, INC.
39-PA-8560
In Commercial Distribution

  • 00840019900508 ()
39-PA-8560

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

Reform Pedicle Screw System - 00840019900492

8.5 x 55mm Polyaxial Screw
PRECISION SPINE, INC.
39-PA-8555
In Commercial Distribution

  • 00840019900492 ()
39-PA-8555

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

Reform Pedicle Screw System - 00840019900485

8.5 x 50mm Polyaxial Screw
PRECISION SPINE, INC.
39-PA-8550
In Commercial Distribution

  • 00840019900485 ()
39-PA-8550

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

Reform Pedicle Screw System - 00840019900478

8.5 x 45mm Polyaxial Screw
PRECISION SPINE, INC.
39-PA-8545
In Commercial Distribution

  • 00840019900478 ()
39-PA-8545

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

Reform Pedicle Screw System - 00840019900461

8.5 x 40mm Polyaxial Screw
PRECISION SPINE, INC.
39-PA-8540
In Commercial Distribution

  • 00840019900461 ()
39-PA-8540

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

Reform Pedicle Screw System - 00840019900454

ø8.5 x 35 mm POLYAXIAL SCREW
PRECISION SPINE, INC.
39-PA-8535
In Commercial Distribution

  • 00840019900454 ()
39-PA-8535

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