A non-sterile device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is t
| Company | Devices | Share |
|---|---|---|
| Genesys Orthopedics Systems Llc | 736 | 97% |
| Diomedical Co.,Ltd. | 25 | 3% |
| Xtant Medical Holdings, Inc. | 1 | 0% |
Company = labeler of record on GUDID. 3 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 | 736 |
| MQP | Spinal Vertebral Body Replacement Device | 121 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 121 |
| PEK | Spinous process plate | 25 |
| LRP | Tray, Surgical | 1 |
Use these as the dimensions to specify in a tender line.
762 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Lumbar interspinous decompression spacer, non-sterile", from 3 companies. The largest labeler is Genesys Orthopedics Systems Llc with 97% of records.
MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), MQP (Spinal Vertebral Body Replacement Device), ODP (Intervertebral Fusion Device With Bone Graft, Cervical), PEK (Spinous process plate)
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.