FDA 510(k)

Synergy Disc Instruments

Número K: K253392 · 2026-03-27

Data da decisão2026-03-27

Código do produtoQLQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synergy Disc Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Synergy Spine Solutions, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K253392. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synergy Disc Instruments?

Synergy Disc Instruments is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Synergy Spine Solutions, Inc.. The 510(k) number is K253392.

When did Synergy Disc Instruments receive FDA 510(k) clearance?

Synergy Disc Instruments received FDA 510(k) clearance on 2026-03-27, under 510(k) number K253392.

Who is the listed applicant for Synergy Disc Instruments?

The FDA 510(k) record lists Synergy Spine Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synergy Disc Instruments?

The FDA product code for Synergy Disc Instruments is QLQ.

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Fonte oficial

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