Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Spinal Kinetics, LLC. It received FDA 510(k) clearance on 2022-06-02 under approval 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. It is manufactured by Spinal Kinetics, LLC. The 510(k) number is K220861.

When was M6-C Artificial Cervical Disc Instruments AS approved by the FDA?

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

What company makes M6-C Artificial Cervical Disc Instruments AS?

M6-C Artificial Cervical Disc Instruments AS is manufactured by Spinal Kinetics, LLC.

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

NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT07568366 AI in Endoscopic Transsphenoidal Surgery NOT_YET_RECRUITING

Other Devices by Spinal Kinetics, LLC

PMA P170036Prosthesis, intervertebral disc

Related Devices (Code: QLQ)

K211757Simplify DiscNuvasive, Inc. K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC K242869prodisc® L InstrumentsCentinel Spine, LLC K241117M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine K250554prodisc® L InstrumentsCentinel Spine, LLC

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.

↑