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FDA 510(k)

DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS

K-Number: K122395 · 2012-10-31

ApplicantDePuy Orthopaedics, Inc.
Decision Date2012-10-31
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2012-10-31 under 510(k) number K122395. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS?

DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K122395.

When did DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS receive FDA 510(k) clearance?

DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS received FDA 510(k) clearance on 2012-10-31, under 510(k) number K122395.

Who is the listed applicant for DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS?

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

What is the FDA product code for DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS?

The FDA product code for DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS is HSN.

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Related Devices (Code: HSN)

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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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