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)

ATH CERAMIC UHMWPE TOTAL HIP SYSTEM

K-Number: K890472 · 1989-09-01

ApplicantKinamed, Inc.
Decision Date1989-09-01
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ATH CERAMIC UHMWPE TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Inc.. It received FDA 510(k) clearance on 1989-09-01 under 510(k) number K890472. 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 ATH CERAMIC UHMWPE TOTAL HIP SYSTEM?

ATH CERAMIC UHMWPE TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-01. The listed applicant is Kinamed, Inc.. The 510(k) number is K890472.

When did ATH CERAMIC UHMWPE TOTAL HIP SYSTEM receive FDA 510(k) clearance?

ATH CERAMIC UHMWPE TOTAL HIP SYSTEM received FDA 510(k) clearance on 1989-09-01, under 510(k) number K890472.

Who is the listed applicant for ATH CERAMIC UHMWPE TOTAL HIP SYSTEM?

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

What is the FDA product code for ATH CERAMIC UHMWPE TOTAL HIP SYSTEM?

The FDA product code for ATH CERAMIC UHMWPE TOTAL HIP SYSTEM 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 Kinamed, 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.

K122049NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEMK072250SUPERCABLE GRIP AND PLATE SYSTEMK050897NAVIPRO SHOULDER SOFTWARE MODULEK033668NAVIPRO KNEE SOFTWARE MODULEK032950GEM INSET PATELLAR COMPONENTK030256ISO-ELASTIC CERCLAGE SYSTEM

View all 33 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.

↑