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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 Modular - 00840019938570

Modular Offset Tulip Assembly, 17mm
PRECISION SPINE, INC.
39-WT-0417
In Commercial Distribution

  • 00840019938570 ()
39-WT-0417

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

Reform Ti Modular - 00840019938563

Modular Offset Tulip Assembly, 14mm
PRECISION SPINE, INC.
39-WT-0414
In Commercial Distribution

  • 00840019938563 ()
39-WT-0414

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

Reform Ti Modular - 00840019938556

Modular Offset Tulip Assembly, 11mm
PRECISION SPINE, INC.
39-WT-0411
In Commercial Distribution

  • 00840019938556 ()
39-WT-0411

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

Reform Midline Cortical Screw System - 00840019937788

Implant Build Kit: 4.5 - 7.5 + Reduction Tulip
PRECISION SPINE, INC.
59-BK-1014
In Commercial Distribution

  • 00840019937788 ()
59-BK-1014

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

Reform Midline Cortical Screw System - 00840019937771

Implant Build Kit: 4.5 - 6.5 + Reduction Tulip
PRECISION SPINE, INC.
59-BK-1013
In Commercial Distribution

  • 00840019937771 ()
59-BK-1013

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

Reform Midline Cortical Screw System - 00840019937764

Implant Build Kit: 4.5 - 7.5
PRECISION SPINE, INC.
59-BK-1012
In Commercial Distribution

  • 00840019937764 ()
59-BK-1012

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

Reform Midline Cortical Screw System - 00840019937757

Implant Build Kit: 4.5 - 6.5
PRECISION SPINE, INC.
59-BK-1011
In Commercial Distribution

  • 00840019937757 ()
59-BK-1011

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

Reform Midline Cortical Screw System - 00840019937740

Ø7.5mm Bone Screw Build Kit - Pedicular
PRECISION SPINE, INC.
59-BK-0507
In Commercial Distribution

  • 00840019937740 ()
59-BK-0507

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

Reform Midline Cortical Screw System - 00840019937733

Ø6.5mm Bone Screw Build Kit - Pedicular
PRECISION SPINE, INC.
59-BK-0506
In Commercial Distribution

  • 00840019937733 ()
59-BK-0506

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

Reform Midline Cortical Screw System - 00840019937726

Ø5.5mm Bone Screw Build Kit - Pedicular
PRECISION SPINE, INC.
59-BK-0505
In Commercial Distribution

  • 00840019937726 ()
59-BK-0505

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