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FDA 510(k)

P.F.C. UNICONDYLAR KNEE SYSTEM

K-Number: K910968 · 1991-08-26

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1991-08-26
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C. UNICONDYLAR KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K910968. 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.F.C. UNICONDYLAR KNEE SYSTEM?

P.F.C. UNICONDYLAR KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K910968.

When did P.F.C. UNICONDYLAR KNEE SYSTEM receive FDA 510(k) clearance?

P.F.C. UNICONDYLAR KNEE SYSTEM received FDA 510(k) clearance on 1991-08-26, under 510(k) number K910968.

Who is the listed applicant for P.F.C. UNICONDYLAR KNEE SYSTEM?

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

What is the FDA product code for P.F.C. UNICONDYLAR KNEE SYSTEM?

The FDA product code for P.F.C. UNICONDYLAR KNEE SYSTEM is HRY.

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Other records listing Johnson & Johnson Orthopaedics, Inc. as applicant

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.

K931466PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRIK935452P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENTK940190ULTIMA UNIPOLAR MODULAR HEADK933275P.F.C. CERAMIC HIP HEADK932595ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTORK931655P.F.C. BIPOLAR HIP SYSTEM

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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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