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FDA 510(k)

ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM

K-Number: K926395 · 1994-03-10

ApplicantDepuy, Inc.
Decision Date1994-03-10
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1994-03-10 under 510(k) number K926395. 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 ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM?

ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-10. The listed applicant is Depuy, Inc.. The 510(k) number is K926395.

When did ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM receive FDA 510(k) clearance?

ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM received FDA 510(k) clearance on 1994-03-10, under 510(k) number K926395.

Who is the listed applicant for ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM?

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

What is the FDA product code for ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM?

The FDA product code for ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM is LZO.

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Other records listing Depuy, 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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