K253392 is an FDA 510(k) clearance for the Synergy Disc Instruments. This device is classified as a Manual Instruments Designed For Use With Total Disc Replacement Devices (Class II - Special Controls, product code QLQ).
Submitted by Synergy Spine Solutions, Inc. (Louisville, US). The FDA issued a Cleared decision on March 27, 2026, 178 days after receiving the submission on September 30, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4515. The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices..
| 510(k) Number | K253392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | March 27, 2026 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QLQ - Manual Instruments Designed For Use With Total Disc Replacement Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4515 |
| Definition | The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices. |