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FDA 510(k)

HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE

K-Number: K820030 · 1982-02-05

ApplicantHowmedica Corp.
Decision Date1982-02-05
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-02-05 under 510(k) number K820030. 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 HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE?

HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE is a medical device that received FDA 510(k) clearance on 1982-02-05. The listed applicant is Howmedica Corp.. The 510(k) number is K820030.

When did HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE receive FDA 510(k) clearance?

HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE received FDA 510(k) clearance on 1982-02-05, under 510(k) number K820030.

Who is the listed applicant for HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE?

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

What is the FDA product code for HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE?

The FDA product code for HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE is HRY.

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Other records listing Howmedica Corp. 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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