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FDA 510(k)

OMNIFIT II EPF HIP STEM SERIES

K-Number: K911585 · 1991-07-01

ApplicantOsteonics Corp.
Decision Date1991-07-01
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNIFIT II EPF HIP STEM SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K911585. 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 OMNIFIT II EPF HIP STEM SERIES?

OMNIFIT II EPF HIP STEM SERIES is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is Osteonics Corp.. The 510(k) number is K911585.

When did OMNIFIT II EPF HIP STEM SERIES receive FDA 510(k) clearance?

OMNIFIT II EPF HIP STEM SERIES received FDA 510(k) clearance on 1991-07-01, under 510(k) number K911585.

Who is the listed applicant for OMNIFIT II EPF HIP STEM SERIES?

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

What is the FDA product code for OMNIFIT II EPF HIP STEM SERIES?

The FDA product code for OMNIFIT II EPF HIP STEM SERIES is MEH.

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Other records listing Osteonics 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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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