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FDA 510(k)

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL

K-Number: K910563 · 1991-05-23

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1991-05-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL 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 1991-05-23 under 510(k) number K910563. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL?

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K910563.

When did P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL receive FDA 510(k) clearance?

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL received FDA 510(k) clearance on 1991-05-23, under 510(k) number K910563.

Who is the listed applicant for P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL?

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.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL?

The FDA product code for P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL is JWH.

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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: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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