FDA 510(k)

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System

Numéro K : K170643 · 2017-04-14

DemandeurRti Surgical, Inc. Dba Rti Biologics

Date de décision2017-04-14

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc. Dba Rti Biologics. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K170643. 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 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Rti Surgical, Inc. Dba Rti Biologics. The 510(k) number is K170643.

When did Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System receive FDA 510(k) clearance?

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2017-04-14, under 510(k) number K170643.

Who is the listed applicant for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

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

What is the FDA product code for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

The FDA product code for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is MAX.

Essais cliniques associés

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Dispositifs connexes (Code : MAX)

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Source officielle

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