An implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacr
| Company | Devices | Share |
|---|---|---|
| Sivantage, Inc. | 123 | 59% |
| Zavation Llc | 29 | 14% |
| 4Web Medical | 21 | 10% |
| Spinal Simplicity, Llc | 15 | 7% |
| Surgentec, Llc | 9 | 4% |
| Medical Designs Llc | 6 | 3% |
| Signus Medizintechnik Gmbh | 4 | 2% |
| Captiva Spine, Inc. | 1 | 0% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| OUR | Sacroiliac Joint Fixation | 204 |
| HWC | Screw, Fixation, Bone | 36 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 |
Use these as the dimensions to specify in a tender line.
208 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sacroiliac joint intra-articular arthrodesis implant", from 8 companies. The largest labeler is Sivantage, Inc. with 59% of records.
OUR (Sacroiliac Joint Fixation), HWC (Screw, Fixation, Bone), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
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.