A small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g.,
| Company | Devices | Share |
|---|---|---|
| Medicon Eg. Chirurgiemechaniker-Genossenschaft | 272 | 57% |
| Visionare, Llc | 155 | 32% |
| Osteomed Llc | 23 | 5% |
| Surgident Co.,Ltd. | 18 | 4% |
| Suncoast Dental, Inc | 12 | 2% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| JEY | PLATE, BONE | 276 |
| DZL | Screw, Fixation, Intraosseous | 185 |
| HWC | Screw, fixation, bone | 10 |
| DZL | SCREW, FIXATION, INTRAOSSEOUS | 5 |
| KCT | Sterilization wrap containers, trays, cassettes & other acce | 3 |
| GWO | Plate, cranioplasty, preformed, alterable | 1 |
Use these as the dimensions to specify in a tender line.
480 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, non-sterile", from 5 companies. The largest labeler is Medicon Eg. Chirurgiemechaniker-Genossenschaft with 57% of records.
JEY (PLATE, BONE), DZL (Screw, Fixation, Intraosseous), HWC (Screw, fixation, bone), 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.