FDA 510(k)

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL

K-Nummer: K161710 · 2017-06-29

AntragstellerSpinal Analytics & Geometrical Impant Co, LLC

Entscheidungsdatum2017-06-29

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Analytics & Geometrical Impant Co, LLC. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K161710. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL?

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Spinal Analytics & Geometrical Impant Co, LLC. The 510(k) number is K161710.

When did SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL receive FDA 510(k) clearance?

SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL received FDA 510(k) clearance on 2017-06-29, under 510(k) number K161710.

Who is the listed applicant for SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL?

The FDA 510(k) record lists Spinal Analytics & Geometrical Impant Co, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL?

The FDA product code for SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL is MAX.

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