prodisc® L Instruments
FDA 510(k) clearance K242869 · decided 2024-12-17
Clearance details
- K-number
- K242869
- Device name
- prodisc® L Instruments
- Applicant
- Centinel Spine, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-09-20
- Decision date
- 2024-12-17
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- QLQ
- Device class
- 2
- Regulation number
- 888.4515
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, 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 |
|---|---|---|
| Synergy Disc Instruments (K253392) | Synergy Spine Solutions, Inc. | 2026-03-27 |
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| prodisc C SK and prodisc C Vivo (P070001/S025) | Centinel Spine, LLC | 2025-10-10 |
| PRODISC L (P050010/S027) | Centinel Spine, LLC | 2025-09-02 |
| prodisc L (P050010/S028) | Centinel Spine, LLC | 2025-07-30 |
| prodisc® C (P070001/S029) | Centinel Spine, LLC | 2025-07-30 |
| PRODISC -L TOTAL DISC REPLACEMENT DEVICE (P050010/S025) | Centinel Spine, LLC | 2025-06-04 |
| prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK (P070001/S028) | Centinel Spine, LLC | 2025-06-04 |
| prodisc® L (P050010/S026) | Centinel Spine, LLC | 2025-01-17 |
| prodisc C (P070001/S027) | Centinel Spine, LLC | 2024-08-07 |