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FDA 510(k)

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments

K-Number: K221848 · 2022-08-19

ApplicantCentinel Spine, LLC
Decision Date2022-08-19
Product CodeQLQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments is a medical device manufactured by Centinel Spine, LLC. It received FDA 510(k) clearance on 2022-08-19 under approval number K221848. 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 C SK, prodisc C Nova, and prodisc C Vivo Instruments?

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Centinel Spine, LLC. The 510(k) number is K221848.

When was prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments approved by the FDA?

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments received FDA 510(k) clearance on 2022-08-19, under approval number K221848.

What company makes prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments?

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments is manufactured by Centinel Spine, LLC.

What is the FDA product code for prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments?

The FDA product code for prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments is QLQ.

Other Devices by Centinel Spine, LLC

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Official Source

View on FDA Database →

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

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