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FDA 510(k)

2 PIECE MODULAR HIP STEM

K-Number: K013106 · 2002-04-03

ApplicantHowmedica Osteonics Corp.
Decision Date2002-04-03
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

2 PIECE MODULAR HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K013106. 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 2 PIECE MODULAR HIP STEM?

2 PIECE MODULAR HIP STEM is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K013106.

When did 2 PIECE MODULAR HIP STEM receive FDA 510(k) clearance?

2 PIECE MODULAR HIP STEM received FDA 510(k) clearance on 2002-04-03, under 510(k) number K013106.

Who is the listed applicant for 2 PIECE MODULAR HIP STEM?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2 PIECE MODULAR HIP STEM?

The FDA product code for 2 PIECE MODULAR HIP STEM is LZO.

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Other records listing Howmedica Osteonics Corp. as applicant

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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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