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FDA 510(k)

CONSENSUS PCL SUBSITUTING TIBIAL INSERT

K-Number: K953443 · 1996-04-26

ApplicantU.S. Medical Products, Inc.
Decision Date1996-04-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS PCL SUBSITUTING TIBIAL INSERT is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Medical Products, Inc.. It received FDA 510(k) clearance on 1996-04-26 under 510(k) number K953443. 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 CONSENSUS PCL SUBSITUTING TIBIAL INSERT?

CONSENSUS PCL SUBSITUTING TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 1996-04-26. The listed applicant is U.S. Medical Products, Inc.. The 510(k) number is K953443.

When did CONSENSUS PCL SUBSITUTING TIBIAL INSERT receive FDA 510(k) clearance?

CONSENSUS PCL SUBSITUTING TIBIAL INSERT received FDA 510(k) clearance on 1996-04-26, under 510(k) number K953443.

Who is the listed applicant for CONSENSUS PCL SUBSITUTING TIBIAL INSERT?

The FDA 510(k) record lists U.S. Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONSENSUS PCL SUBSITUTING TIBIAL INSERT?

The FDA product code for CONSENSUS PCL SUBSITUTING TIBIAL INSERT is JWH.

Related Clinical Trials

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Other records listing U.S. Medical Products, 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.

K962215CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTERK954818CONSENSUS POSTERIOR STABILIZED KNEEK952943CONSENSUS ALL POLY TIBIAK960302CONSENSUS ACETABULAR SHELL, ALL UHMWPEK960340CONSENSUS APEX DOME HOLE PLUGK960156CONSENSUS 32MM COCRMO FEMORAL HEAD

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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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