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FDA 510(k)

P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH

K-Number: K810060 · 1981-04-07

ApplicantHowmedica Corp.
Decision Date1981-04-07
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1981-04-07 under 510(k) number K810060. 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 P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH?

P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH is a medical device that received FDA 510(k) clearance on 1981-04-07. The listed applicant is Howmedica Corp.. The 510(k) number is K810060.

When did P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH receive FDA 510(k) clearance?

P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH received FDA 510(k) clearance on 1981-04-07, under 510(k) number K810060.

Who is the listed applicant for P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH?

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 P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH?

The FDA product code for P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH 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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