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 ZIRCONIA C-TAPER FEMORAL BEARING HEAD

K-Number: K925695 · 1993-04-20

ApplicantOsteonics Corp.
Decision Date1993-04-20
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K925695. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD?

OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Osteonics Corp.. The 510(k) number is K925695.

When did OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD receive FDA 510(k) clearance?

OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD received FDA 510(k) clearance on 1993-04-20, under 510(k) number K925695.

Who is the listed applicant for OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD?

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 ZIRCONIA C-TAPER FEMORAL BEARING HEAD?

The FDA product code for OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD is LZO.

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: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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.

↑