510(k) K250554
- Device
- prodisc® L Instruments
- Applicant
- Centinel Spine, LLC
- 510(k) number
- K250554
- Product code
- QLQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-25
- Date received
- 2025-02-25
- Regulation
- 888.4515
- Classification name
- Manual Instruments Designed For Use With Total Disc Replacement Devices
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jessica Staub
- Address
- 900 Airport Rd., Suite 3b West Chester PA US 19380 19380
FDA Registration Numbers#
- 3030412764
- 3010370500
- 3009144915
- 3016050940
- 3014213973
- 2031966
- 9610612
- 3012447612
- 3007494564
- 3004788213
- 2183449
Source Documents#
Other 510(k) Records For Product Code QLQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253392 | Synergy Disc Instruments | Synergy Spine Solutions, Inc. | 2026-03-27 |
| K242869 | prodisc® L Instruments | Centinel Spine, LLC | 2024-12-17 |
| K241117 | M6-C™ Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine | 2024-06-21 |
| K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | 2023-07-13 |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | Centinel Spine, LLC | 2022-08-19 |
| K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | 2022-06-02 |
| K211757 | Simplify Disc | Nuvasive, Inc. | 2021-08-20 |