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FDA 510(k)

BIOLOX DELTA CERAMIC FEMORAL HEAD

K-Number: K071535 · 2007-11-19

ApplicantZimmer, Inc.
Decision Date2007-11-19
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX DELTA CERAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2007-11-19 under 510(k) number K071535. 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 BIOLOX DELTA CERAMIC FEMORAL HEAD?

BIOLOX DELTA CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2007-11-19. The listed applicant is Zimmer, Inc.. The 510(k) number is K071535.

When did BIOLOX DELTA CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

BIOLOX DELTA CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 2007-11-19, under 510(k) number K071535.

Who is the listed applicant for BIOLOX DELTA CERAMIC FEMORAL HEAD?

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

What is the FDA product code for BIOLOX DELTA CERAMIC FEMORAL HEAD?

The FDA product code for BIOLOX DELTA CERAMIC FEMORAL HEAD is LZO.

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Other records listing Zimmer, Inc. as applicant

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Related Devices (Code: LZO)

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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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