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)

BDH FEMORAL COMPONENT

K-Number: K821343 · 1982-06-03

ApplicantIntermedics Orthopedics
Decision Date1982-06-03
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BDH FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K821343. 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 BDH FEMORAL COMPONENT?

BDH FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Intermedics Orthopedics. The 510(k) number is K821343.

When did BDH FEMORAL COMPONENT receive FDA 510(k) clearance?

BDH FEMORAL COMPONENT received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821343.

Who is the listed applicant for BDH FEMORAL COMPONENT?

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

What is the FDA product code for BDH FEMORAL COMPONENT?

The FDA product code for BDH FEMORAL COMPONENT 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 Intermedics Orthopedics 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.

K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTIK970498NATURAL-KNEE II REVISION FEMORAL SPACER LUGSK970166NATURAL-HIP SYSTEM COCR REVISION STEMK970567SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDSK964357NATURAL-HIP SYSTEM COCR STEMK964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA

View all 108 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.

↑