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FDA 510(k)

AGILITY LP TOTAL ANKLE PROSTHESIS

K-Number: K053569 · 2006-03-31

ApplicantDePuy Orthopaedics, Inc.
Decision Date2006-03-31
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 2006-03-31 under 510(k) number K053569. 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 AGILITY LP TOTAL ANKLE PROSTHESIS?

AGILITY LP TOTAL ANKLE PROSTHESIS is a medical device that received FDA 510(k) clearance on 2006-03-31. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K053569.

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

AGILITY LP TOTAL ANKLE PROSTHESIS received FDA 510(k) clearance on 2006-03-31, under 510(k) number K053569.

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

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

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Related Devices (Code: HSN)

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K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

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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