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FDA 510(k)

M6-C™ Single Use, Disposable Instrumentation

K-Number: K241117 · 2024-06-21

ApplicantSpinal Kinetics / Orthofix / Seaspine
Decision Date2024-06-21
Product CodeQLQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M6-C™ Single Use, Disposable Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Kinetics / Orthofix / Seaspine. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K241117. 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™ Single Use, Disposable Instrumentation?

M6-C™ Single Use, Disposable Instrumentation is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Spinal Kinetics / Orthofix / Seaspine. The 510(k) number is K241117.

When did M6-C™ Single Use, Disposable Instrumentation receive FDA 510(k) clearance?

M6-C™ Single Use, Disposable Instrumentation received FDA 510(k) clearance on 2024-06-21, under 510(k) number K241117.

Who is the listed applicant for M6-C™ Single Use, Disposable Instrumentation?

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

What is the FDA product code for M6-C™ Single Use, Disposable Instrumentation?

The FDA product code for M6-C™ Single Use, Disposable Instrumentation is QLQ.

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, LLCK231769activL® Next Generation InstrumentationAesculap Implants Systems, LLCK221848prodisc C SK, prodisc C Nova, and prodisc C Vivo 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.

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