Data / Medical devices / United States / Synergy Spine Solutions Inc
Synergy Spine Solutions Inc: FDA-registered device maker in Louisville, CO, United States, 1 510(k) clearance and 1 PMA approval
Synergy Spine Solutions Inc is registered with the FDA (registration 3014213973) in Louisville, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated March 27, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014213973
- Address
- 357 S McCaslin Blvd, Suite 120, Louisville, CO, United States, 80027
- Owner or operator
- Synergy Spine Solutions Inc. (10056585)
- Roles
- Manufacturer
- First device listed
- March 4, 2026
- Registered through
- 2027
- Brand names listed
- Synergy Disc, Synergy Disc Instruments
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Manual Instruments Designed For Use With Total Disc Replacement Devices | QLQ | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Intervertebral Disc | MJO | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 2026 | K253392 | Synergy Disc Instruments | QLQ | Substantially Equivalent | Synergy Spine Solutions, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 26, 2026 | P250028 | Synergy Disc | MJO | 3 | September 17, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Manual Instruments Designed For Use With Total Disc Replacement Devices
- All makers of Prosthesis, Intervertebral Disc
Updated September 17, 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.