A hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds
| Company | Devices | Share |
|---|---|---|
| George Tiemann & Co. | 96 | 50% |
| Sontec Instruments, Inc. | 54 | 28% |
| Fusion Orthopedics, Llc | 17 | 9% |
| Zavation Llc | 9 | 5% |
| Hayden Medical, Inc. | 3 | 2% |
| Shukla Medical | 3 | 2% |
| Globus Medical, Inc. | 3 | 2% |
| Rp Medical Inc | 2 | 1% |
| Spineology Inc. | 2 | 1% |
| Arthrex, Inc. | 1 | 1% |
| Spierings Orthopaedics B.V. | 1 | 1% |
| Mps Micro Precision Systems Ag | 1 | 1% |
Company = labeler of record on GUDID. 12 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 | 64 |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 43 |
| HWM | OSTEOTOME | 41 |
| GDZ | Handle, Scalpel | 17 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 8 |
| LXH | Orthopedic Manual Surgical Instrument | 7 |
Use these as the dimensions to specify in a tender line.
192 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic osteotome handle", from 12 companies. The largest labeler is George Tiemann & Co. with 50% of records.
GFI (OSTEOTOME, MANUAL), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HWM (OSTEOTOME), GDZ (Handle, Scalpel)
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.