A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., o
| Company | Devices | Share |
|---|---|---|
| Osstem Implant Co., Ltd. | 732 | 5% |
| Synthes Gmbh | 583 | 4% |
| Medtronic Sofamor Danek, Inc. | 511 | 3% |
| Smith & Nephew, Inc. | 500 | 3% |
| Alphatec Spine, Inc. | 487 | 3% |
| Megagen Implant Co. Ltd | 486 | 3% |
| Shukla Medical | 332 | 2% |
| Highridge Medical, Llc | 320 | 2% |
| Sin Sistema De Implante Nacional S/A | 276 | 2% |
| Biomet Orthopedics, Llc | 275 | 2% |
| Globus Medical, Inc. | 272 | 2% |
| Nuvasive, Inc. | 252 | 2% |
Company = labeler of record on GUDID. 376 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 |
|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | 3,670 |
| HXX | SCREWDRIVER | 3,427 |
| HXX | Screwdriver | 1,703 |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1,265 |
| NDP | Accessories, implant, dental, endosseous | 1,238 |
| LXH | Orthopedic Manual Surgical Instrument | 613 |
Use these as the dimensions to specify in a tender line.
15,548 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical screwdriver, reusable", from 376 companies. The largest labeler is Osstem Implant Co., Ltd. with 5% of records.
NDP (Accessories, Implant, Dental, Endosseous), HXX (SCREWDRIVER), HXX (Screwdriver), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)
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.