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FDA 510(k)

CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER

K-Number: K891083 · 1989-06-09

ApplicantDepuy, Inc.
Decision Date1989-06-09
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K891083. 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 CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER?

CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Depuy, Inc.. The 510(k) number is K891083.

When did CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER receive FDA 510(k) clearance?

CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER received FDA 510(k) clearance on 1989-06-09, under 510(k) number K891083.

Who is the listed applicant for CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER?

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 CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER?

The FDA product code for CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER 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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