Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP

K-Number: K912654 · 1991-08-16

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

Device Summary

OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP 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 K912654. 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 EPF DUAL GEOMETRY ACETABULAR CUP?

OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP 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 K912654.

When did OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP receive FDA 510(k) clearance?

OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP received FDA 510(k) clearance on 1991-08-16, under 510(k) number K912654.

Who is the listed applicant for OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP?

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 EPF DUAL GEOMETRY ACETABULAR CUP?

The FDA product code for OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP is MEH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 178 devices →

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.

↑