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FDA 510(k)

VERSAFIT CUP DOUBLE MOBILITY SYSTEM

K-Number: K083116 · 2009-04-07

ApplicantMedacta International S.A.
Decision Date2009-04-07
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERSAFIT CUP DOUBLE MOBILITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2009-04-07 under 510(k) number K083116. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSAFIT CUP DOUBLE MOBILITY SYSTEM?

VERSAFIT CUP DOUBLE MOBILITY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-07. The listed applicant is Medacta International S.A.. The 510(k) number is K083116.

When did VERSAFIT CUP DOUBLE MOBILITY SYSTEM receive FDA 510(k) clearance?

VERSAFIT CUP DOUBLE MOBILITY SYSTEM received FDA 510(k) clearance on 2009-04-07, under 510(k) number K083116.

Who is the listed applicant for VERSAFIT CUP DOUBLE MOBILITY SYSTEM?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSAFIT CUP DOUBLE MOBILITY SYSTEM?

The FDA product code for VERSAFIT CUP DOUBLE MOBILITY SYSTEM is MEH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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