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FDA 510(k)

DEPUY PRESERVATION UNICONDYLAR TIBIA

K-Number: K040268 · 2004-05-05

ApplicantDePuy Orthopaedics, Inc.
Decision Date2004-05-05
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY PRESERVATION UNICONDYLAR TIBIA 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 2004-05-05 under 510(k) number K040268. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY PRESERVATION UNICONDYLAR TIBIA?

DEPUY PRESERVATION UNICONDYLAR TIBIA is a medical device that received FDA 510(k) clearance on 2004-05-05. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K040268.

When did DEPUY PRESERVATION UNICONDYLAR TIBIA receive FDA 510(k) clearance?

DEPUY PRESERVATION UNICONDYLAR TIBIA received FDA 510(k) clearance on 2004-05-05, under 510(k) number K040268.

Who is the listed applicant for DEPUY PRESERVATION UNICONDYLAR TIBIA?

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 PRESERVATION UNICONDYLAR TIBIA?

The FDA product code for DEPUY PRESERVATION UNICONDYLAR TIBIA is HRY.

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Related Devices (Code: HRY)

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K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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