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)

BOHN FEMORAL COMPONENT

K-Number: K000262 · 2000-04-03

ApplicantBiomet Manufacturing, Inc.
Decision Date2000-04-03
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BOHN FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2000-04-03 under 510(k) number K000262. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOHN FEMORAL COMPONENT?

BOHN FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 2000-04-03. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K000262.

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

BOHN FEMORAL COMPONENT received FDA 510(k) clearance on 2000-04-03, under 510(k) number K000262.

Who is the listed applicant for BOHN FEMORAL COMPONENT?

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

What is the FDA product code for BOHN FEMORAL COMPONENT?

The FDA product code for BOHN FEMORAL COMPONENT is MEH.

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 Biomet Manufacturing, 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.

K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK113121COMPREHENSIVE REVERSE SHOULDERK080685HIPLOC COMPRESSION HIP SCREWK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEM

View all 32 devices →

Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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.

↑