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Device Explorer · FDA GUDID · GMDN 37272

Trans-facet-screw internal spinal fixation system, sterile

A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae wi

US‑registered devices22,163in commercial distribution
Companies16labelers on GUDID
Single‑use100%of device records
Sterile13%labelled sterile
Prescription6%Rx‑only share
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Share of device records

Globus Medical, Inc.19,46088%
Sintea Plustek Srl7113%
Implanet5482%
Biomet Spine Llc5462%
Spinefrontier, Inc.4352%
Signature Orthopaedics Pty Ltd1191%
Choice Spine, Lp1181%
New Era Orthopedics Llc670%

Top labelers

CompanyDevicesShare
Globus Medical, Inc.19,46088%
Sintea Plustek Srl7113%
Implanet5482%
Biomet Spine Llc5462%
Spinefrontier, Inc.4352%
Signature Orthopaedics Pty Ltd1191%
Choice Spine, Lp1181%
New Era Orthopedics Llc670%
Nuvasive Specialized Orthopedics, Inc.430%
Ldr Spine Usa, Inc.400%
Orthopediatrics Corp.280%
Seaspine Orthopedics Corporation220%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FacetBRIDGEJAZZ SystemJAZZ FRAMEJAZZ LOCKIMPLANET SPINE SYSTEMREVERESI-LOKN/ACREOELLIPSEQUARTEXAERIALREVOLVESILCBEACONZYFUSE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL17,306
MNIORTHOSIS, SPINAL PEDICLE FIXATION15,450
MNHOrthosis, spondylolisthesis spinal fixation15,403
NKBOrthosis, spinal pedicle fixation, for degenerative disc dis15,316
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY15,036
OSHPedicle screw spinal system, adolescent idiopathic scoliosis10,367

GMDN & GCC registration

  • GMDN code 37272 · non‑implantable
  • Single‑use 100% · sterile 13% · Rx‑only 6% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 19,831Length (Millimeter) · 19,365Width (Millimeter) · 611Height (Millimeter) · 509Lumen/Inner Diameter (Millimeter) · 161Angle (degree) · 22

Use these as the dimensions to specify in a tender line.

How many trans-facet-screw internal spinal fixation system, sterile products are registered in the US?

22,163 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Trans-facet-screw internal spinal fixation system, sterile", from 16 companies. The largest labeler is Globus Medical, Inc. with 88% of records.

Which FDA product codes apply?

KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), MNI (ORTHOSIS, SPINAL PEDICLE FIXATION), MNH (Orthosis, spondylolisthesis spinal fixation), NKB (Orthosis, spinal pedicle fixation, for degenerative disc dis)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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