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FDA 510(k)

CONSENSUS ACETABULAR SHELL, ALL UHMWPE

K-Number: K960302 · 1996-04-01

ApplicantU.S. Medical Products, Inc.
Decision Date1996-04-01
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS ACETABULAR SHELL, ALL UHMWPE 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 1996-04-01 under 510(k) number K960302. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONSENSUS ACETABULAR SHELL, ALL UHMWPE?

CONSENSUS ACETABULAR SHELL, ALL UHMWPE is a medical device that received FDA 510(k) clearance on 1996-04-01. The listed applicant is U.S. Medical Products, Inc.. The 510(k) number is K960302.

When did CONSENSUS ACETABULAR SHELL, ALL UHMWPE receive FDA 510(k) clearance?

CONSENSUS ACETABULAR SHELL, ALL UHMWPE received FDA 510(k) clearance on 1996-04-01, under 510(k) number K960302.

Who is the listed applicant for CONSENSUS ACETABULAR SHELL, ALL UHMWPE?

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 ACETABULAR SHELL, ALL UHMWPE?

The FDA product code for CONSENSUS ACETABULAR SHELL, ALL UHMWPE is JDI.

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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 KNEEK953443CONSENSUS PCL SUBSITUTING TIBIAL INSERTK952943CONSENSUS ALL POLY TIBIAK960340CONSENSUS APEX DOME HOLE PLUGK960156CONSENSUS 32MM COCRMO FEMORAL HEAD

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Related Devices (Code: JDI)

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.

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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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