An implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondy
| Company | Devices | Share |
|---|---|---|
| Pinnacle Spine Group, Llc | 390 | 21% |
| Life Spine, Inc. | 372 | 20% |
| Cg Medtech Co.,Ltd. | 293 | 15% |
| Xtant Medical Holdings, Inc. | 206 | 11% |
| Biomet Spine Llc | 138 | 7% |
| Highridge Medical, Llc | 113 | 6% |
| Spinefrontier, Inc. | 100 | 5% |
| Southern Spine Llc | 80 | 4% |
| Difusion Technologies, Inc. | 42 | 2% |
| Restor3D, Inc. | 36 | 2% |
| Spinal Simplicity, Llc | 34 | 2% |
| Zavation Llc | 28 | 1% |
Company = labeler of record on GUDID. 20 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 |
|---|---|---|
| PEK | Spinous process plate | 782 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 444 |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | 430 |
| PEK | Spinous Process Plate | 154 |
| MAX | Intervertebral fusion device with bone graft, lumbar | 69 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 24 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
1,901 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Interspinous spinal fixation implant", from 20 companies. The largest labeler is Pinnacle Spine Group, Llc with 21% of records.
PEK (Spinous process plate), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), 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.