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FDA 510(k)

PORTRAIT FEMORAL COMPONENT

K-Number: K010560 · 2001-03-20

ApplicantBiomet, Inc.
Decision Date2001-03-20
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PORTRAIT FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-03-20 under 510(k) number K010560. 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 PORTRAIT FEMORAL COMPONENT?

PORTRAIT FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Biomet, Inc.. The 510(k) number is K010560.

When did PORTRAIT FEMORAL COMPONENT receive FDA 510(k) clearance?

PORTRAIT FEMORAL COMPONENT received FDA 510(k) clearance on 2001-03-20, under 510(k) number K010560.

Who is the listed applicant for PORTRAIT FEMORAL COMPONENT?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTRAIT FEMORAL COMPONENT?

The FDA product code for PORTRAIT FEMORAL COMPONENT is LZO.

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Other records listing Biomet, Inc. 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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