A non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to cl
| Company | Devices | Share |
|---|---|---|
| Fusion Orthopedics, Llc | 66 | 78% |
| Osteomed Llc | 7 | 8% |
| Flow-Fx | 6 | 7% |
| Osteocentric Technologies, Inc. | 2 | 2% |
| Field Orthopaedics Pty Ltd | 2 | 2% |
| Advanced Orthopaedic Solutions, Inc. | 1 | 1% |
| Preat Corporation | 1 | 1% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| HWC | Screw, Fixation, Bone | 48 |
| HTW | Bit, Drill | 15 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 12 |
| HTW | BIT, DRILL | 6 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 6 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
Use these as the dimensions to specify in a tender line.
85 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cannulated surgical drill bit, single-use, non-sterile", from 7 companies. The largest labeler is Fusion Orthopedics, Llc with 78% of records.
HWC (Screw, Fixation, Bone), HTW (Bit, Drill), MBI (Fastener, Fixation, Nondegradable, Soft Tissue), HTW (BIT, DRILL)
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.