FDA 510(k)

M6-C Artificial Cervical Disc Instruments AS

Номер K: K220861 · 2022-06-02

Дата решения2022-06-02

Код продуктаQLQ

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

M6-C Artificial Cervical Disc Instruments AS is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Kinetics, LLC. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K220861. 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 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. The listed applicant is Spinal Kinetics, LLC. The 510(k) number is K220861.

When did M6-C Artificial Cervical Disc Instruments AS receive FDA 510(k) clearance?

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

Who is the listed applicant for M6-C Artificial Cervical Disc Instruments AS?

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

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.

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 K241117M6-C™ Одноразовое, disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC

Официальный источник

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