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FDA 510(k)

DEPUY FEMORAL HEADS

K-Number: K011533 · 2002-01-28

ApplicantDePuy Orthopaedics, Inc.
Decision Date2002-01-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY FEMORAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2002-01-28 under 510(k) number K011533. 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 DEPUY FEMORAL HEADS?

DEPUY FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 2002-01-28. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K011533.

When did DEPUY FEMORAL HEADS receive FDA 510(k) clearance?

DEPUY FEMORAL HEADS received FDA 510(k) clearance on 2002-01-28, under 510(k) number K011533.

Who is the listed applicant for DEPUY FEMORAL HEADS?

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

What is the FDA product code for DEPUY FEMORAL HEADS?

The FDA product code for DEPUY FEMORAL HEADS is LZO.

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Other records listing DePuy Orthopaedics, 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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