Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)

K-Number: K964431 · 1997-08-11

ApplicantBiomet, Inc.
Decision Date1997-08-11
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1997-08-11 under 510(k) number K964431. 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 ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)?

ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) is a medical device that received FDA 510(k) clearance on 1997-08-11. The listed applicant is Biomet, Inc.. The 510(k) number is K964431.

When did ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) receive FDA 510(k) clearance?

ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) received FDA 510(k) clearance on 1997-08-11, under 510(k) number K964431.

Who is the listed applicant for ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)?

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 ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)?

The FDA product code for ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) is LZO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 418 devices →

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.

↑