prodisc® L Instruments
FDA 510(k) K242869 · Centinel Spine, LLC
510(k) numberK242869
Submission
- Device name
- prodisc® L Instruments
- Applicant
- Centinel Spine, LLC
West Chester, PA, US - Received
- September 20, 2024
- Decision date
- December 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4515
- Specialty
- Orthopedic
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
Other 510(k)s with product code QLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262639 | BAGUERA® C Cervical Disc Surgical InstrumentsQLQ · Traditional | Spineart SA | 08/14/2026SE |
| K253392 | Synergy Disc InstrumentsQLQ · Traditional | Synergy Spine Solutions, Inc. | 03/27/2026SE |
| K250554 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 04/25/2025SE |
| K241117 | M6-C Single Use, Disposable InstrumentationQLQ · Traditional | Spinal Kinetics / Orthofix / Seaspine | 06/21/2024SE |
| K231769 | activL® Next Generation InstrumentationQLQ · Special | Aesculap Implants Systems, LLC | 07/13/2023SE |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsQLQ · Traditional | Centinel Spine, LLC | 08/19/2022SE |
| K220861 | M6-C Artificial Cervical Disc Instruments ASQLQ · Traditional | Spinal Kinetics, LLC | 06/02/2022SE |
| K211757 | Simplify DiscQLQ · Traditional | Nuvasive, Inc. | 08/20/2021SE |
More from Nuvasive, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250554 | prodisc® L InstrumentsQLQ · Traditional | 04/25/2025SE |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsQLQ · Traditional | 08/19/2022SE |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…MAX · Traditional | 05/08/2018SE |
| K152211 | PCT SystemNKG · Traditional | 12/01/2015SE |
| K150053 | STALIF C; STALIF C-TiOVE · Traditional | 06/24/2015SE |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVD · Traditional | 06/08/2015SE |
| K141942 | Midline II TiOVD · Traditional | 11/07/2014SE |
| K142079 | Stalif Cti, Stalif COVE · Traditional | 10/24/2014SE |
| K133200 | Stalif C(R)OVE · Traditional | 05/08/2014SE |
| K133286 | Midline (TM)OVD · Special | 01/09/2014SE |
Questions and answers
When was prodisc® L Instruments cleared by the FDA?
prodisc® L Instruments (K242869) received a 510(k) decision of Substantially Equivalent on December 17, 2024, 88 days after the submission was received.
What is the product code of K242869?
The FDA product code is QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices, a Class II (moderate risk) device regulated under 21 CFR 888.4515.