A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing,
| Company | Devices | Share |
|---|---|---|
| Restor3D, Inc. | 78 | 45% |
| Fusion Orthopedics, Llc | 68 | 39% |
| Hyperflex Medical Inc. | 5 | 3% |
| Biomet Orthopedics, Llc | 4 | 2% |
| Subchondral Solutions, Inc. | 4 | 2% |
| Eca Medical Instruments | 2 | 1% |
| Pioneer Surgical Technology, Inc. | 2 | 1% |
| Heinz Kurz Gmbh | 2 | 1% |
| Ames Medical Prosthetic Solutions S.A. | 2 | 1% |
| Wright Medical Technology, Inc. | 1 | 1% |
| Altus Spine, Llc | 1 | 1% |
| In2Bones Usa, Llc | 1 | 1% |
Company = labeler of record on GUDID. 15 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 |
|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | 105 |
| HWC | Screw, Fixation, Bone | 20 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 14 |
| MJW | Prosthesis, Subtalar, Plug, Polymer | 12 |
| JDR | Staple, Fixation, Bone | 7 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 6 |
Use these as the dimensions to specify in a tender line.
173 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical implant/trial-implant/sizer holder, single-use", from 15 companies. The largest labeler is Restor3D, Inc. with 45% of records.
LXH (Orthopedic Manual Surgical Instrument), HWC (Screw, Fixation, Bone), KWH (Prosthesis, Toe, Constrained, Polymer), MJW (Prosthesis, Subtalar, Plug, Polymer)
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.
Add surgical implant/trial-implant/sizer holder, single-use to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.
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.