Data / Medical devices / Manual Instruments Designed For Use With Total Disc Replacement Devices / United States
FDA-registered makers of Manual Instruments Designed For Use With Total Disc Replacement Devices in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Manual Instruments Designed For Use With Total Disc Replacement Devices (product code QLQ). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Manual Instruments Designed For Use With Total Disc Replacement Devices
- Product code
- QLQ
- Country
- United States
Makers of Manual Instruments Designed For Use With Total Disc Replacement Devices in the United States
| 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 |
| 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 |
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.