FDA 510(k)

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION

K-Number: K080885 · 2008-04-28

Decision Date2008-04-28

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION 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 2008-04-28 under 510(k) number K080885. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION?

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2008-04-28. The listed applicant is Medacta International S.A.. The 510(k) number is K080885.

When did MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION receive FDA 510(k) clearance?

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION received FDA 510(k) clearance on 2008-04-28, under 510(k) number K080885.

Who is the listed applicant for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION?

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 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION?

The FDA product code for MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION is JDI.

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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.