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)

BTM TOTAL HIP SYSTEM

K-Number: K852420 · 1985-06-28

ApplicantKirschner Medical Corp.
Decision Date1985-06-28
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BTM TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kirschner Medical Corp.. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K852420. 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 BTM TOTAL HIP SYSTEM?

BTM TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K852420.

When did BTM TOTAL HIP SYSTEM receive FDA 510(k) clearance?

BTM TOTAL HIP SYSTEM received FDA 510(k) clearance on 1985-06-28, under 510(k) number K852420.

Who is the listed applicant for BTM TOTAL HIP SYSTEM?

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

What is the FDA product code for BTM TOTAL HIP SYSTEM?

The FDA product code for BTM TOTAL HIP SYSTEM 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 Kirschner Medical 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.

K940537KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEMK936274KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEMK942891SUMMIT TOTAL HIP SYSTEMK941486INTEGRITY TOTAL HIP SYSTEM, NON-POROUSK933843LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATEDK935951KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM

View all 76 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.

↑