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FDA 510(k)

M6-C Artificial Cervical Disc Instruments AS

K-Number: K220861 · 2022-06-02

ApplicantSpinal Kinetics, LLC
Decision Date2022-06-02
Product CodeQLQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M6-C Artificial Cervical Disc Instruments AS is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Kinetics, LLC. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K220861. 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 M6-C Artificial Cervical Disc Instruments AS?

M6-C Artificial Cervical Disc Instruments AS is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Spinal Kinetics, LLC. The 510(k) number is K220861.

When did M6-C Artificial Cervical Disc Instruments AS receive FDA 510(k) clearance?

M6-C Artificial Cervical Disc Instruments AS received FDA 510(k) clearance on 2022-06-02, under 510(k) number K220861.

Who is the listed applicant for M6-C Artificial Cervical Disc Instruments AS?

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

What is the FDA product code for M6-C Artificial Cervical Disc Instruments AS?

The FDA product code for M6-C Artificial Cervical Disc Instruments AS is QLQ.

Related Clinical Trials

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.

NCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITING

Other records listing Spinal Kinetics, 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 P170036Prosthesis, intervertebral disc

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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