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)

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

K-Number: K040225 · 2004-05-06

ApplicantOsteoimplant Technology, Inc.
Decision Date2004-05-06
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteoimplant Technology, Inc.. It received FDA 510(k) clearance on 2004-05-06 under 510(k) number K040225. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM?

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-06. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K040225.

When did OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM receive FDA 510(k) clearance?

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM received FDA 510(k) clearance on 2004-05-06, under 510(k) number K040225.

Who is the listed applicant for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM?

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

What is the FDA product code for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM?

The FDA product code for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM is KWZ.

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 Osteoimplant Technology, 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.

K040685Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATEDK041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK032729Z-SERIES MODULAR TOTAL HIP SYSTEMK030608OTI BONE CEMENT PLUGK022779OTI UNICONDULAR INTERPOSITIONAL SPACERK021822R120 MODULAR TOTAL HIP SYSTEM

View all 21 devices →

Related Devices (Code: KWZ)

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.

K241461Mpact Constrained LinerMedacta International S.A.K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UCK162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P.K161610EXPRT Revision Hip SystemEncore Medical L.P.K122139SMITH & NEPHEW R3 CONSTRAINED LINERSSmith & Nephew, Inc.

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.

↑