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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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Reform POCT System - 00840019967730

Ø3.5 x 18mm Polyaxial Screw - M/L Bias
PRECISION SPINE, INC.
55-PM-3518
In Commercial Distribution

  • 00840019967730 ()
55-PM-3518

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

Reform POCT System - 00840019967723

Ø3.5 x 16mm Polyaxial Screw - M/L Bias
PRECISION SPINE, INC.
55-PM-3516
In Commercial Distribution

  • 00840019967723 ()
55-PM-3516

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

Reform POCT System - 00840019967716

Ø3.5 x 14mm Polyaxial Screw - M/L Bias
PRECISION SPINE, INC.
55-PM-3514
In Commercial Distribution

  • 00840019967716 ()
55-PM-3514

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

Reform POCT System - 00840019967709

Ø3.5 x 12mm Polyaxial Screw - M/L Bias
PRECISION SPINE, INC.
55-PM-3512
In Commercial Distribution

  • 00840019967709 ()
55-PM-3512

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

Reform POCT System - 00840019967693

Ø3.5 x 10mm Polyaxial Screw - M/L Bias
PRECISION SPINE, INC.
55-PM-3510
In Commercial Distribution

  • 00840019967693 ()
55-PM-3510

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

Reform POCT System - 00840019967686

Ø3.5 x 8mm Polyaxial Screw - M/L Bias
PRECISION SPINE, INC.
55-PM-3508
In Commercial Distribution

  • 00840019967686 ()
55-PM-3508

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

Reform® Ti CT Modular MIS Pedicle Screw System - 00840019967624

Modular MIS Extended Tab Tulip, Closed Ring
PRECISION SPINE, INC.
64-MT-0404
In Commercial Distribution

  • 00840019967624 ()
64-MT-0404

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

Reform® Ti CT Modular MIS Pedicle Screw System - 00840019967617

Closed Ring Extended Tab Tulip Instrument Kit, Rod Inserter with Stop
PRECISION SPINE, INC.
64-BK-0204
In Commercial Distribution

  • 00840019967617 ()
64-BK-0204

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform® Ti CT Modular MIS Pedicle Screw System - 00840019967600

Closed Ring Extended Tab Tulip Instrument Kit, Pass Thru Rod Inserter
PRECISION SPINE, INC.
64-BK-0203
In Commercial Distribution

  • 00840019967600 ()
64-BK-0203

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform® Ti CT Modular MIS Pedicle Screw System - 00840019967594

Closed Extended Tab Tulip Kit
PRECISION SPINE, INC.
64-BK-0124
In Commercial Distribution

  • 00840019967594 ()
64-BK-0124

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