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FDA 510(k)

ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)

K-Number: K925345 · 1994-03-10

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

Device Summary

ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-03-10 under 510(k) number K925345. 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 ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)?

ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) is a medical device that received FDA 510(k) clearance on 1994-03-10. The listed applicant is Biomet, Inc.. The 510(k) number is K925345.

When did ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) receive FDA 510(k) clearance?

ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) received FDA 510(k) clearance on 1994-03-10, under 510(k) number K925345.

Who is the listed applicant for ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)?

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 ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)?

The FDA product code for ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) is LZO.

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Other records listing Biomet, Inc. as applicant

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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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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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