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)

AUSTIN MOORE TYPE HIP PROTHESIS

K-Number: K905349 · 1990-12-11

ApplicantO'Tec Corp.
Decision Date1990-12-11
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AUSTIN MOORE TYPE HIP PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is O'Tec Corp.. It received FDA 510(k) clearance on 1990-12-11 under 510(k) number K905349. 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 AUSTIN MOORE TYPE HIP PROTHESIS?

AUSTIN MOORE TYPE HIP PROTHESIS is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is O'Tec Corp.. The 510(k) number is K905349.

When did AUSTIN MOORE TYPE HIP PROTHESIS receive FDA 510(k) clearance?

AUSTIN MOORE TYPE HIP PROTHESIS received FDA 510(k) clearance on 1990-12-11, under 510(k) number K905349.

Who is the listed applicant for AUSTIN MOORE TYPE HIP PROTHESIS?

The FDA 510(k) record lists O'Tec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUSTIN MOORE TYPE HIP PROTHESIS?

The FDA product code for AUSTIN MOORE TYPE HIP PROTHESIS 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 O'Tec Corp. 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.

K943293SCC22/ SCC26 SHOWER COMMODE CHAIRK910093FUTURA FEMORAL HIP STEMK905358CANCELLOUS SCREWK905355BROAD SELF-COMPRESSING PLATEK905347HAGIE PINK905357CORTICAL BONE SCREW (EUROPEAN STYLE)

View all 23 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.

↑