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FDA 510(k)

CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM

K-Number: K935453 · 1994-07-13

ApplicantU.S. Medical Products, Inc.
Decision Date1994-07-13
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM 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 1994-07-13 under 510(k) number K935453. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM?

CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is U.S. Medical Products, Inc.. The 510(k) number is K935453.

When did CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM receive FDA 510(k) clearance?

CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM received FDA 510(k) clearance on 1994-07-13, under 510(k) number K935453.

Who is the listed applicant for CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM?

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(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM?

The FDA product code for CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM is MEH.

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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 INSERTK960302CONSENSUS ACETABULAR SHELL, ALL UHMWPEK952943CONSENSUS ALL POLY TIBIAK960340CONSENSUS APEX DOME HOLE PLUG

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

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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