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FDA 510(k)

OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C

K-Number: K911728 · 1991-08-16

ApplicantOsteonics Corp.
Decision Date1991-08-16
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K911728. 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(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C?

OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Osteonics Corp.. The 510(k) number is K911728.

When did OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C receive FDA 510(k) clearance?

OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C received FDA 510(k) clearance on 1991-08-16, under 510(k) number K911728.

Who is the listed applicant for OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C?

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(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C?

The FDA product code for OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C is MEH.

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Other records listing Osteonics Corp. as applicant

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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.

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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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