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FDA 510(k)

PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI

K-Number: K931466 · 1994-12-06

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1994-12-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI 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 1994-12-06 under 510(k) number K931466. 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 PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI?

PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI is a medical device that received FDA 510(k) clearance on 1994-12-06. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K931466.

When did PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI receive FDA 510(k) clearance?

PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI received FDA 510(k) clearance on 1994-12-06, under 510(k) number K931466.

Who is the listed applicant for PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI?

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 PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI?

The FDA product code for PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI 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.

K935452P.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 SYSTEMK933867UNIVERSAL INSET PATELLA

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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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