Consulting Wallah › Device Explorer › Orthopaedic implants › Craniofacial bone screw, bioabsorbable
Device Explorer · FDA GUDID · GMDN 46637

Craniofacial bone screw, 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 devices211in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Stryker Leibinger Gmbh & Co. Kg10047%
Biomet Microfixation, Inc6531%
Synthes Gmbh2713%
Kls-Martin L.P.105%
Osteomed Llc94%

Top labelers

CompanyDevicesShare
Stryker Leibinger Gmbh & Co. Kg10047%
Biomet Microfixation, Inc6531%
Synthes Gmbh2713%
Kls-Martin L.P.105%
Osteomed Llc94%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DELTAIQ LactoSorb System1.5 LactoSorb System2.0 LactoSorb System2.8 LactoSorb SystemOsteoMedLACTOSORB SYSTEM2.5 LACTOSORB SYSTEM2.0 LACTOSORB SYSTEM1.5 LACTOSORB SYSTEMRapidSorbRESORB X, STERILE

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

FDA product codes

CodeNameDevices
JEYPLATE, BONE114
HWCScrew, fixation, bone69
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE56
HBWFASTENER, PLATE, CRANIOPLASTY52
HRSPLATE, FIXATION, BONE41
DZLSCREW, FIXATION, INTRAOSSEOUS32

GMDN & GCC registration

  • GMDN code 46637 · implantable
  • Single‑use 100% · sterile 98% · Rx‑only 100% · 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) · 109

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

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

211 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Craniofacial bone screw, bioabsorbable", from 5 companies. The largest labeler is Stryker Leibinger Gmbh & Co. Kg with 47% of records.

Which FDA product codes apply?

JEY (PLATE, BONE), HWC (Screw, fixation, bone), MAI (FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE), HBW (FASTENER, PLATE, CRANIOPLASTY)

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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