Data / Medical devices / Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices (QLR): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices (product code QLR, Class 2, 21 CFR 888.4520). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on December 16, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QLR
- Device class
- 2
- Regulation
- 888.4520
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| France | 1 |
Makers of Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
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 | Specification developer | 1 | December 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 16, 2025. 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.