A hand-held, manually-operated, instrument that has various forms of fine ridged cutting surfaces along part of or all of its working end that is used for cutting and smoothing (filing) bone tissue. It is made of high-grade steel and may be a one-piece instrum
| Company | Devices | Share |
|---|---|---|
| Seaspine Orthopedics Corporation | 134 | 75% |
| Blustone Synergy, Llc | 24 | 13% |
| Sklar Corporation | 16 | 9% |
| Smith & Nephew, Inc. | 4 | 2% |
| Corin Ltd | 1 | 1% |
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 |
|---|---|---|
| HTR | RASP | 82 |
| FZT | CUTTER, SURGICAL | 40 |
| HTR | Rasp | 24 |
| EMI | FILE, BONE, SURGICAL | 16 |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 14 |
| HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, | 2 |
Use these as the dimensions to specify in a tender line.
179 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone file", from 5 companies. The largest labeler is Seaspine Orthopedics Corporation with 75% of records.
HTR (RASP), FZT (CUTTER, SURGICAL), HTR (Rasp), EMI (FILE, BONE, SURGICAL)
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.