Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL

K-Number: K914439 · 1991-10-23

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1991-10-23
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL 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 1991-10-23 under 510(k) number K914439. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL?

P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K914439.

When did P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL receive FDA 510(k) clearance?

P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL received FDA 510(k) clearance on 1991-10-23, under 510(k) number K914439.

Who is the listed applicant for P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL?

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.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL?

The FDA product code for P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL is HSX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 22 devices →

Related Devices (Code: HSX)

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.

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.

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.

↑