FDA 510(k)

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System

Numéro K : K163506 · 2017-06-19

Date de décision2017-06-19

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Vertera, Inc.. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K163506. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System?

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Vertera, Inc.. The 510(k) number is K163506.

When did Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System received FDA 510(k) clearance on 2017-06-19, under 510(k) number K163506.

Who is the listed applicant for Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System?

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

What is the FDA product code for Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System?

The FDA product code for Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is MAX.

Essais cliniques associés

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Dispositifs connexes (Code : MAX)

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Source officielle

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