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FDA 510(k)

GMK RESUFACING PATELLA SIZE 4

K-Number: K113571 · 2012-01-27

ApplicantMedacta International
Decision Date2012-01-27
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK RESUFACING PATELLA SIZE 4 is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2012-01-27 under 510(k) number K113571. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK RESUFACING PATELLA SIZE 4?

GMK RESUFACING PATELLA SIZE 4 is a medical device that received FDA 510(k) clearance on 2012-01-27. The listed applicant is Medacta International. The 510(k) number is K113571.

When did GMK RESUFACING PATELLA SIZE 4 receive FDA 510(k) clearance?

GMK RESUFACING PATELLA SIZE 4 received FDA 510(k) clearance on 2012-01-27, under 510(k) number K113571.

Who is the listed applicant for GMK RESUFACING PATELLA SIZE 4?

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

What is the FDA product code for GMK RESUFACING PATELLA SIZE 4?

The FDA product code for GMK RESUFACING PATELLA SIZE 4 is JWH.

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Related Devices (Code: JWH)

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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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