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)

ZIRCONIUM ALLOY UNI-POLAR HEAD

K-Number: K934353 · 1994-04-25

ApplicantSmith & Nephew Richards, Inc.
Decision Date1994-04-25
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIRCONIUM ALLOY UNI-POLAR HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1994-04-25 under 510(k) number K934353. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIRCONIUM ALLOY UNI-POLAR HEAD?

ZIRCONIUM ALLOY UNI-POLAR HEAD is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K934353.

When did ZIRCONIUM ALLOY UNI-POLAR HEAD receive FDA 510(k) clearance?

ZIRCONIUM ALLOY UNI-POLAR HEAD received FDA 510(k) clearance on 1994-04-25, under 510(k) number K934353.

Who is the listed applicant for ZIRCONIUM ALLOY UNI-POLAR HEAD?

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

What is the FDA product code for ZIRCONIUM ALLOY UNI-POLAR HEAD?

The FDA product code for ZIRCONIUM ALLOY UNI-POLAR HEAD is KWL.

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 Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEM

View all 87 devices →

Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical 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.

↑