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FDA 510(k)

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED

K-Number: K934729 · 1994-07-22

ApplicantImplantology Corp.
Decision Date1994-07-22
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED is the device name listed in this FDA 510(k) record. The listed applicant is Implantology Corp.. It received FDA 510(k) clearance on 1994-07-22 under 510(k) number K934729. 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 UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED?

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is Implantology Corp.. The 510(k) number is K934729.

When did UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED receive FDA 510(k) clearance?

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED received FDA 510(k) clearance on 1994-07-22, under 510(k) number K934729.

Who is the listed applicant for UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED?

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

What is the FDA product code for UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED?

The FDA product code for UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED is MEH.

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Other records listing Implantology Corp. 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.

K915529FPC/SFPC/RFPC ACETABULAR COMPONENTK915528BHR BIPOLAR FEMORAL HEAD COMPONENTK915527CPS ACETABULAR COMPONENTK915385PPC HIP STEM COMPONENTK915391FPC HIP STEM COMPONENTK924099UFC HIP STEM COMPONENT

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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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