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FDA 510(k)

OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES

K-Number: K851404 · 1985-06-18

ApplicantOsteonics Corp.
Decision Date1985-06-18
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNIFIT THREADED ACETABULAR COMPONENTS 2005 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 1985-06-18 under 510(k) number K851404. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES?

OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES is a medical device that received FDA 510(k) clearance on 1985-06-18. The listed applicant is Osteonics Corp.. The 510(k) number is K851404.

When did OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES receive FDA 510(k) clearance?

OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES received FDA 510(k) clearance on 1985-06-18, under 510(k) number K851404.

Who is the listed applicant for OMNIFIT THREADED ACETABULAR COMPONENTS 2005 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 THREADED ACETABULAR COMPONENTS 2005 SERIES?

The FDA product code for OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES is KWA.

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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: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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