Synergy Disc Instruments
FDA 510(k) clearance K253392 · decided 2026-03-27
Clearance details
- K-number
- K253392
- Device name
- Synergy Disc Instruments
- Applicant
- Synergy Spine Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-30
- Decision date
- 2026-03-27
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- QLQ
- Device class
- 2
- Regulation number
- 888.4515
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| prodisc® L Instruments (K242869) | Centinel Spine, LLC | 2024-12-17 |
| M6-C™ Single Use, Disposable Instrumentation (K241117) | Spinal Kinetics / Orthofix / Seaspine | 2024-06-21 |
| activL® Next Generation Instrumentation (K231769) | Aesculap Implants Systems, LLC | 2023-07-13 |
| prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) | Centinel Spine, LLC | 2022-08-19 |
| M6-C Artificial Cervical Disc Instruments AS (K220861) | Spinal Kinetics, LLC | 2022-06-02 |
| Simplify Disc (K211757) | Nuvasive, Inc. | 2021-08-20 |
Recalls involving this device
No recalls on record reference this clearance.