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FDA 510(k)

OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

K-Number: K990203 · 1999-02-18

ApplicantOsteonics Corp.
Decision Date1999-02-18
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1999-02-18 under 510(k) number K990203. 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 OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS?

OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS is a medical device that received FDA 510(k) clearance on 1999-02-18. The listed applicant is Osteonics Corp.. The 510(k) number is K990203.

When did OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS receive FDA 510(k) clearance?

OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS received FDA 510(k) clearance on 1999-02-18, under 510(k) number K990203.

Who is the listed applicant for OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS?

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 PRIMARY SECUR-FIT PLUS HIP STEMS?

The FDA product code for OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS is MEH.

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Other records listing Osteonics Corp. as applicant

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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.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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