A sterile implantable metal sphere used to stabilize interspinous processes from L3 to S1 to promote intervertebral body fusion. It is inserted into the disc space between two vertebral bodies, and is specifically designed to be used with a bone graft to hold
| Company | Devices | Share |
|---|---|---|
| Captiva Spine, Inc. | 1,197 | 99% |
| Addivation Medical, Llc | 16 | 1% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1,005 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 208 |
Use these as the dimensions to specify in a tender line.
1,213 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal fusion sphere", from 2 companies. The largest labeler is Captiva Spine, Inc. with 99% of records.
MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
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.