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FDA 510(k)

FIXED BEARING UNI COMPONENT

K-Number: K021621 · 2002-06-05

ApplicantBiomet, Inc.
Decision Date2002-06-05
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXED BEARING UNI COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2002-06-05 under 510(k) number K021621. 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 FIXED BEARING UNI COMPONENT?

FIXED BEARING UNI COMPONENT is a medical device that received FDA 510(k) clearance on 2002-06-05. The listed applicant is Biomet, Inc.. The 510(k) number is K021621.

When did FIXED BEARING UNI COMPONENT receive FDA 510(k) clearance?

FIXED BEARING UNI COMPONENT received FDA 510(k) clearance on 2002-06-05, under 510(k) number K021621.

Who is the listed applicant for FIXED BEARING UNI COMPONENT?

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

What is the FDA product code for FIXED BEARING UNI COMPONENT?

The FDA product code for FIXED BEARING UNI COMPONENT is HRY.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: HRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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