FDA 510(k)

prodisc® L Instruments

K-Number: K250554 · 2025-04-25

Decision Date2025-04-25

Product CodeQLQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

prodisc® L Instruments is a medical device manufactured by Centinel Spine, LLC. It received FDA 510(k) clearance on 2025-04-25 under approval number K250554. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the prodisc® L Instruments?

prodisc® L Instruments is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Centinel Spine, LLC. The 510(k) number is K250554.

When was prodisc® L Instruments approved by the FDA?

prodisc® L Instruments received FDA 510(k) clearance on 2025-04-25, under approval number K250554.

What company makes prodisc® L Instruments?

prodisc® L Instruments is manufactured by Centinel Spine, LLC.

What is the FDA product code for prodisc® L Instruments?

The FDA product code for prodisc® L Instruments is QLQ.

Other Devices by Centinel Spine, LLC

K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments K242869prodisc® L Instruments PMA P050010Prosthesis, intervertebral disc PMA P070001Prosthesis, intervertebral disc

Related Devices (Code: QLQ)

K211757Simplify DiscNuvasive, Inc. K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC K220861M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC K242869prodisc® L InstrumentsCentinel Spine, LLC K241117M6-C Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.