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FDA 510(k)

P.F.C. BIPOLAR HIP SYSTEM

K-Number: K931655 · 1994-06-09

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1994-06-09
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C. BIPOLAR HIP 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 1994-06-09 under 510(k) number K931655. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.F.C. BIPOLAR HIP SYSTEM?

P.F.C. BIPOLAR HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-09. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K931655.

When did P.F.C. BIPOLAR HIP SYSTEM receive FDA 510(k) clearance?

P.F.C. BIPOLAR HIP SYSTEM received FDA 510(k) clearance on 1994-06-09, under 510(k) number K931655.

Who is the listed applicant for P.F.C. BIPOLAR HIP 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. BIPOLAR HIP SYSTEM?

The FDA product code for P.F.C. BIPOLAR HIP SYSTEM is KWY.

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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 RESTRICTORK933867UNIVERSAL INSET PATELLA

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Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus 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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