FDA 510(k)

M6-C™ Одноразовое, disposable Instrumentation

Номер K: K241117 · 2024-06-21

ЗаявительSpinal Kinetics / Orthofix / Seaspine

Дата решения2024-06-21

Код продуктаQLQ

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: QLQ)

K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc.K250554prodisc® L InstrumentsCentinel Spine, LLC K242869prodisc® L InstrumentsCentinel Spine, LLC K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC

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