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FDA 510(k)

HYDROXYAPATITE COATED PROFILE(R) HIP STEM

K-Number: K910156 · 1991-06-07

ApplicantDepuy, Inc.
Decision Date1991-06-07
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HYDROXYAPATITE COATED PROFILE(R) HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1991-06-07 under 510(k) number K910156. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROXYAPATITE COATED PROFILE(R) HIP STEM?

HYDROXYAPATITE COATED PROFILE(R) HIP STEM is a medical device that received FDA 510(k) clearance on 1991-06-07. The listed applicant is Depuy, Inc.. The 510(k) number is K910156.

When did HYDROXYAPATITE COATED PROFILE(R) HIP STEM receive FDA 510(k) clearance?

HYDROXYAPATITE COATED PROFILE(R) HIP STEM received FDA 510(k) clearance on 1991-06-07, under 510(k) number K910156.

Who is the listed applicant for HYDROXYAPATITE COATED PROFILE(R) HIP STEM?

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

What is the FDA product code for HYDROXYAPATITE COATED PROFILE(R) HIP STEM?

The FDA product code for HYDROXYAPATITE COATED PROFILE(R) HIP STEM is MEH.

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Other records listing Depuy, Inc. as applicant

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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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