A non-powered implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a si
| Company | Devices | Share |
|---|---|---|
| Kls-Martin L.P. | 550 | 63% |
| Synthes Gmbh | 144 | 16% |
| Biomet Microfixation, Inc | 93 | 11% |
| Osteomed Llc | 59 | 7% |
| Stryker Leibinger Gmbh & Co. Kg | 25 | 3% |
| Medicon Eg. Chirurgiemechaniker-Genossenschaft | 5 | 1% |
| Mis Implants Technologies Ltd. | 1 | 0% |
| Nuvasive, Inc. | 1 | 0% |
Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR | 989 |
| JEY | PLATE, BONE | 147 |
| PBJ | Cranial Distraction System | 74 |
| DZL | SCREW, FIXATION, INTRAOSSEOUS | 16 |
| HWC | Screw, fixation, bone | 4 |
| FZX | Guide, surgical, instrument | 2 |
Use these as the dimensions to specify in a tender line.
878 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Implantable craniofacial bone distractor", from 8 companies. The largest labeler is Kls-Martin L.P. with 63% of records.
MQN (EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR), JEY (PLATE, BONE), PBJ (Cranial Distraction System), DZL (SCREW, FIXATION, INTRAOSSEOUS)
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.