Consulting Wallah › Device Explorer › Orthopaedic implants › Craniofacial bone screw, non-bioabsorbable
Device Explorer · FDA GUDID · GMDN 46638

Craniofacial bone screw, non-bioabsorbable

A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in p

US‑registered devices4,192in commercial distribution
Companies26labelers on GUDID
Single‑use99%of device records
Sterile20%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Kls-Martin L.P.1,21329%
Stryker Leibinger Gmbh & Co. Kg84020%
Osteomed Llc41710%
Bioplate, Inc.3147%
Jeil Medical Corporation3117%
Synthes Gmbh2596%
Neoortho Produtos Ortopédicos S/A.1774%
Microware Precision Co., Ltd.1403%

Top labelers

CompanyDevicesShare
Kls-Martin L.P.1,21329%
Stryker Leibinger Gmbh & Co. Kg84020%
Osteomed Llc41710%
Bioplate, Inc.3147%
Jeil Medical Corporation3117%
Synthes Gmbh2596%
Neoortho Produtos Ortopédicos S/A.1774%
Microware Precision Co., Ltd.1403%
Biomet Microfixation, Inc1243%
Cochlear Bone Anchored Solutions Ab662%
Mci-Medical Concept Innovation Inc481%
Southern Medical (Pty) Ltd371%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Universal Mandible AXSMMF AXSHybrid MMF AXSUniversal 2.0 MP AXSAXSUniversal Neuro 3NAUNIVERSAL NEURO 3SMARTLOCKCMFPontoTandry CMF Plate SystemMediconFIX'INNeuroPro®NeuroPro® Low Profile

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

FDA product codes

CodeNameDevices
JEYPLATE, BONE1,837
DZLScrew, Fixation, Intraosseous1,091
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR677
DZLSCREW, FIXATION, INTRAOSSEOUS647
JEYPlate, Bone548
HRSPlate, fixation, bone245

GMDN & GCC registration

  • GMDN code 46638 · implantable
  • Single‑use 99% · sterile 20% · Rx‑only 99% · 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

Length (Millimeter) · 1,888Outer Diameter (Millimeter) · 83Length (Centimeter) · 38Width (Millimeter) · 26Height (Millimeter) · 6Length (Inch) · 3

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

How many craniofacial bone screw, non-bioabsorbable products are registered in the US?

4,192 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Craniofacial bone screw, non-bioabsorbable", from 26 companies. The largest labeler is Kls-Martin L.P. with 29% of records.

Which FDA product codes apply?

JEY (PLATE, BONE), DZL (Screw, Fixation, Intraosseous), MQN (EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR), DZL (SCREW, FIXATION, INTRAOSSEOUS)

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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