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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 a medical device manufactured by Spinal Kinetics / Orthofix / Seaspine. It received FDA 510(k) clearance on 2024-06-21 under approval 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. It is manufactured by Spinal Kinetics / Orthofix / Seaspine. The 510(k) number is K241117.

When was M6-C™ Single Use, Disposable Instrumentation approved by the FDA?

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

What company makes M6-C™ Single Use, Disposable Instrumentation?

M6-C™ Single Use, Disposable Instrumentation is manufactured by Spinal Kinetics / Orthofix / Seaspine.

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 Clinical Trials

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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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