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FDA 510(k)

REPICCI II UNICONDYLAR KNEE

K-Number: K971938 · 1997-08-25

ApplicantBiomet, Inc.
Decision Date1997-08-25
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REPICCI II UNICONDYLAR KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K971938. 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 REPICCI II UNICONDYLAR KNEE?

REPICCI II UNICONDYLAR KNEE is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Biomet, Inc.. The 510(k) number is K971938.

When did REPICCI II UNICONDYLAR KNEE receive FDA 510(k) clearance?

REPICCI II UNICONDYLAR KNEE received FDA 510(k) clearance on 1997-08-25, under 510(k) number K971938.

Who is the listed applicant for REPICCI II UNICONDYLAR KNEE?

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 REPICCI II UNICONDYLAR KNEE?

The FDA product code for REPICCI II UNICONDYLAR KNEE 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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