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FDA 510(k)

OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT

K-Number: K011138 · 2001-07-10

ApplicantBiomet, Inc.
Decision Date2001-07-10
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OXFORD UNICOMPARTMENTAL KNEE FEMORAL 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 2001-07-10 under 510(k) number K011138. 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 OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT?

OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 2001-07-10. The listed applicant is Biomet, Inc.. The 510(k) number is K011138.

When did OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT receive FDA 510(k) clearance?

OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT received FDA 510(k) clearance on 2001-07-10, under 510(k) number K011138.

Who is the listed applicant for OXFORD UNICOMPARTMENTAL KNEE FEMORAL 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 OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT?

The FDA product code for OXFORD UNICOMPARTMENTAL KNEE FEMORAL 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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