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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 the device name listed in this FDA 510(k) record. The listed applicant is Centinel Spine, LLC. It received FDA 510(k) clearance on 2022-08-19 under 510(k) 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. The listed applicant is Centinel Spine, LLC. The 510(k) number is K221848.

When did prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments?

The FDA 510(k) record lists Centinel Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Centinel Spine, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P070001Prosthesis, intervertebral discPMA P050010Prosthesis, intervertebral discK250554prodisc® L InstrumentsK242869prodisc® L InstrumentsK173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX

Related Devices (Code: QLQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SAK253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc.K250554prodisc® L InstrumentsCentinel Spine, LLCK242869prodisc® L InstrumentsCentinel Spine, LLCK241117M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / SeaspineK231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC

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.

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