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M6-C Single Use, Disposable Instrumentation

by Spinal Kinetics / Orthofix / Seaspine

510(k) K241117

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241117 Date21 Jun 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QLQ
Device Class
Class II
Regulation
21 CFR Part 888.4515
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a manual instrument designed for use with total disc replacement devices. It is intended for orthopedic applications as indicated by its device type and regulatory classification.

The device is supplied as a single-use, disposable instrument. It has received FDA 510(k) clearance under product code QLQ and regulation number 888.4515, and is classified as a Class II medical device.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the M6-C Single Use Disposable Instrumentation used for?

    The M6-C Single Use Disposable Instrumentation is a manual instrument designed for use with total disc replacement devices. It is intended for orthopedic applications, specifically to assist in surgical procedures involving these implants, as indicated by its device type and regulatory classification.

  • Is the M6-C Single Use Disposable Instrumentation sterile and single-use?

    Yes, the device is supplied as a single-use, disposable instrument. It is intended for one-time use only and should not be reprocessed or reused, as doing so could compromise patient safety and device performance.

  • What regulatory pathway was used for the M6-C Single Use Disposable Instrumentation?

    The M6-C Single Use Disposable Instrumentation received FDA 510(k) clearance under product code QLQ and regulation number 888.4515. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.

  • Who is the manufacturer of the M6-C Single Use Disposable Instrumentation?

    The M6-C Single Use Disposable Instrumentation is manufactured by Spinal Kinetics, in collaboration with Orthofix and Seaspine. The applicant listed in the FDA 510(k) submission is Spinal Kinetics / Orthofix / Seaspine.