A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create
| Company | Devices | Share |
|---|---|---|
| Biopsybell Srl | 66 | 35% |
| Shanghai Kinetic Medical Co., Ltd. | 57 | 30% |
| Medtronic Sofamor Danek, Inc. | 45 | 24% |
| G21 Srl | 6 | 3% |
| Merit Medical Systems, Inc. | 4 | 2% |
| Benvenue Medical, Inc. | 4 | 2% |
| Mainstream Medical Devices, Llc | 3 | 2% |
| Jiangsu Changmei Medtech Co., Ltd. | 2 | 1% |
| Medshape, Inc. | 1 | 1% |
| Osseon Llc | 1 | 1% |
| Lenoss Medical, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 11 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 | 50 |
| HRX | Arthroscope | 45 |
| NDN | Cement, Bone, Vertebroplasty | 44 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | 43 |
| LXH | Orthopedic Manual Surgical Instrument | 29 |
| GDF | Guide, Needle, Surgical | 20 |
Use these as the dimensions to specify in a tender line.
190 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone access channel kit", from 11 companies. The largest labeler is Biopsybell Srl with 35% of records.
LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HRX (Arthroscope), NDN (Cement, Bone, Vertebroplasty), OCJ (Spinal Channeling Instrument, Vertebroplasty)
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.