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FDA 510(k)

OSTEONICS RESTORATION MONOLITHIC HIP STEM

K-Number: K943774 · 1995-03-06

ApplicantOsteonics Corp.
Decision Date1995-03-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSTEONICS RESTORATION MONOLITHIC HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K943774. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OSTEONICS RESTORATION MONOLITHIC HIP STEM?

OSTEONICS RESTORATION MONOLITHIC HIP STEM is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Osteonics Corp.. The 510(k) number is K943774.

When did OSTEONICS RESTORATION MONOLITHIC HIP STEM receive FDA 510(k) clearance?

OSTEONICS RESTORATION MONOLITHIC HIP STEM received FDA 510(k) clearance on 1995-03-06, under 510(k) number K943774.

Who is the listed applicant for OSTEONICS RESTORATION MONOLITHIC HIP STEM?

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 RESTORATION MONOLITHIC HIP STEM?

The FDA product code for OSTEONICS RESTORATION MONOLITHIC HIP STEM is LZO.

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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: 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.

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