Data / Medical devices / Prosthesis, Spinous Process Spacer/Plate
Prosthesis, Spinous Process Spacer/Plate (NQO): 16 FDA-registered makers in 5 countries
16 establishments in 5 countries are registered with the FDA to make Prosthesis, Spinous Process Spacer/Plate (product code NQO, Class 3). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NQO
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 4 |
| France | 1 |
| Ireland | 1 |
| India | 1 |
Makers of Prosthesis, Spinous Process Spacer/Plate
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Companion Spine | Merignac Gironde, France | Complaint file establishment, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | CLONMEL Tipperary, Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Neuromodulation Corporation | Valencia, CA, United States | Complaint file establishment, Specification developer | 0 | 1 | 3 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Paradigm Spine GmbH | Wurmlingen Baden-Wurttemberg, Germany | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| AUSA Medical Device Pvt Ltd | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bricon Technology GmbH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Spartanburg, SC, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ProCon Implants GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Corona, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unity Tool, Inc. | Osseo, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.