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FDA 510(k)

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT

K-Number: K900638 · 1990-04-30

ApplicantJohnson & Johnson International
Decision Date1990-04-30
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson International. It received FDA 510(k) clearance on 1990-04-30 under 510(k) number K900638. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT?

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1990-04-30. The listed applicant is Johnson & Johnson International. The 510(k) number is K900638.

When did P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT receive FDA 510(k) clearance?

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT received FDA 510(k) clearance on 1990-04-30, under 510(k) number K900638.

Who is the listed applicant for P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT?

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

What is the FDA product code for P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT?

The FDA product code for P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT is KWL.

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Other records listing Johnson & Johnson International 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.

K965198ULTIMA TPS CEMENTED STEMK944937SYNTHETIC ABSORBABLE SUTUREK946245TIELLE* HYDROPOLYMER DRESSINGK942383DERMIVIEW CLEAR TAPEK922918BARRIER SAF-TE HYDROGEL DRAPEK923807P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS

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Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

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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