A hand-held manual surgical device that is an interchangeable component of a chisel or osteotome blade and that functions as a handle designed to mount a compatible blade of these types which is locked into place. Together, this device and the selected blade,
| Company | Devices | Share |
|---|---|---|
| Biomet Spine Llc | 30 | 29% |
| Hpf Srl | 10 | 10% |
| Ldr Spine Usa, Inc. | 7 | 7% |
| Dentis Co. ,Ltd | 7 | 7% |
| Highridge Medical, Llc | 6 | 6% |
| Avalign Technologies, Inc. | 6 | 6% |
| Rz-Medizintechnik Gmbh | 5 | 5% |
| Orthopediatrics Corp. | 5 | 5% |
| Aesculap, Inc. | 4 | 4% |
| Zimmer, Inc. | 4 | 4% |
| Devemed Gmbh | 2 | 2% |
| Varian Medical Systems, Inc. | 2 | 2% |
Company = labeler of record on GUDID. 24 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 |
|---|---|---|
| GFI | OSTEOTOME, MANUAL | 30 |
| LXH | Orthopedic Manual Surgical Instrument | 11 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumba | 9 |
| NDP | Accessories, Implant, Dental, Endosseous | 9 |
| FZO | CHISEL, SURGICAL, MANUAL | 7 |
| EMM | CHISEL, OSTEOTOME, SURGICAL | 7 |
Use these as the dimensions to specify in a tender line.
103 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Chisel/osteotome blade handle", from 24 companies. The largest labeler is Biomet Spine Llc with 29% of records.
GFI (OSTEOTOME, MANUAL), LXH (Orthopedic Manual Surgical Instrument), OVD (Intervertebral Fusion Device With Integrated Fixation, Lumba), NDP (Accessories, Implant, Dental, Endosseous)
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.