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FDA 510(k)

REPICCI II UNICONDYLAR KNEE SYSTEM

K-Number: K020264 · 2002-02-08

ApplicantBiomet Orthopedics, Inc.
Decision Date2002-02-08
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REPICCI II UNICONDYLAR KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2002-02-08 under 510(k) number K020264. 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 SYSTEM?

REPICCI II UNICONDYLAR KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-08. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K020264.

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

REPICCI II UNICONDYLAR KNEE SYSTEM received FDA 510(k) clearance on 2002-02-08, under 510(k) number K020264.

Who is the listed applicant for REPICCI II UNICONDYLAR KNEE SYSTEM?

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

What is the FDA product code for REPICCI II UNICONDYLAR KNEE SYSTEM?

The FDA product code for REPICCI II UNICONDYLAR KNEE SYSTEM is HRY.

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Other records listing Biomet Orthopedics, Inc. as applicant

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K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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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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