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FDA 510(k)

OSTEONICS ACETABULAR WEDGE SYSTEM

K-Number: K971422 · 1997-05-22

ApplicantOsteonics Corp.
Decision Date1997-05-22
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSTEONICS ACETABULAR WEDGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K971422. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OSTEONICS ACETABULAR WEDGE SYSTEM?

OSTEONICS ACETABULAR WEDGE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Osteonics Corp.. The 510(k) number is K971422.

When did OSTEONICS ACETABULAR WEDGE SYSTEM receive FDA 510(k) clearance?

OSTEONICS ACETABULAR WEDGE SYSTEM received FDA 510(k) clearance on 1997-05-22, under 510(k) number K971422.

Who is the listed applicant for OSTEONICS ACETABULAR WEDGE SYSTEM?

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 OSTEONICS ACETABULAR WEDGE SYSTEM?

The FDA product code for OSTEONICS ACETABULAR WEDGE SYSTEM 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)

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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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