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FDA 510(k)

ACTIVE UNICOMPARTMENTAL KNEE SYSTEM

K-Number: K060412 · 2006-05-17

ApplicantAustralian Surgical Design & Manufacture
Decision Date2006-05-17
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIVE UNICOMPARTMENTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Australian Surgical Design & Manufacture. It received FDA 510(k) clearance on 2006-05-17 under 510(k) number K060412. 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 ACTIVE UNICOMPARTMENTAL KNEE SYSTEM?

ACTIVE UNICOMPARTMENTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-05-17. The listed applicant is Australian Surgical Design & Manufacture. The 510(k) number is K060412.

When did ACTIVE UNICOMPARTMENTAL KNEE SYSTEM receive FDA 510(k) clearance?

ACTIVE UNICOMPARTMENTAL KNEE SYSTEM received FDA 510(k) clearance on 2006-05-17, under 510(k) number K060412.

Who is the listed applicant for ACTIVE UNICOMPARTMENTAL KNEE SYSTEM?

The FDA 510(k) record lists Australian Surgical Design & Manufacture as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIVE UNICOMPARTMENTAL KNEE SYSTEM?

The FDA product code for ACTIVE UNICOMPARTMENTAL KNEE SYSTEM 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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