Data / Medical devices / Manual Instruments Designed For Use With Total Disc Replacement Devices
Manual Instruments Designed For Use With Total Disc Replacement Devices (QLQ): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Manual Instruments Designed For Use With Total Disc Replacement Devices (product code QLQ, Class 2, 21 CFR 888.4515). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on October 7, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QLQ
- Device class
- 2
- Regulation
- 888.4515
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Switzerland | 2 |
| Netherlands | 1 |
| France | 1 |
Makers of Manual Instruments Designed For Use With Total Disc Replacement 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 |
|---|---|---|---|---|---|---|---|---|
| Centinel Spine, LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 4 | October 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 1 | August 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 1 | July 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 1 | August 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Spineart SA | Plan-les-Ouates, Switzerland | Complaint file establishment, Specification developer | 1 | August 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Synergy Spine Solutions Inc | Louisville, CO, United States | Manufacturer | 1 | March 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fmi Medisch BV | Schiedam Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LDR Medical | Sainte-Savine Aube, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leitner AG | Busswil Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 7, 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.