prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
FDA 510(k) K221848 · Centinel Spine, LLC
510(k) numberK221848
Submission
- Device name
- prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
- Applicant
- Centinel Spine, LLC
West Chester, PA, US - Received
- June 24, 2022
- Decision date
- August 19, 2022
- 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 |
| K242869 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 12/17/2024SE |
| 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 |
| 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 |
| K242869 | prodisc® L InstrumentsQLQ · Traditional | 12/17/2024SE |
| 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 C SK, prodisc C Nova, and prodisc C Vivo Instruments cleared by the FDA?
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) received a 510(k) decision of Substantially Equivalent on August 19, 2022, 56 days after the submission was received.
What is the product code of K221848?
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.