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)

BHR BIPOLAR FEMORAL HEAD COMPONENT

K-Number: K915528 · 1993-06-29

ApplicantImplantology Corp.
Decision Date1993-06-29
Product CodeLZY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BHR BIPOLAR FEMORAL HEAD COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Implantology Corp.. It received FDA 510(k) clearance on 1993-06-29 under 510(k) number K915528. The device is classified under product code LZY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BHR BIPOLAR FEMORAL HEAD COMPONENT?

BHR BIPOLAR FEMORAL HEAD COMPONENT is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Implantology Corp.. The 510(k) number is K915528.

When did BHR BIPOLAR FEMORAL HEAD COMPONENT receive FDA 510(k) clearance?

BHR BIPOLAR FEMORAL HEAD COMPONENT received FDA 510(k) clearance on 1993-06-29, under 510(k) number K915528.

Who is the listed applicant for BHR BIPOLAR FEMORAL HEAD COMPONENT?

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

What is the FDA product code for BHR BIPOLAR FEMORAL HEAD COMPONENT?

The FDA product code for BHR BIPOLAR FEMORAL HEAD COMPONENT is LZY.

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 Implantology 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.

K934729UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATEDK915529FPC/SFPC/RFPC ACETABULAR COMPONENTK915527CPS ACETABULAR COMPONENTK915385PPC HIP STEM COMPONENTK915391FPC HIP STEM COMPONENTK924099UFC HIP STEM COMPONENT

View all 9 devices →

Related Devices (Code: LZY)

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.

K231448TANDEM Hip SystemSmith & Nephew, Inc.K111145ENDO HEADMedacta InternationalK974442PRE-POWDERED NITRILE EXAMINATION GLOVESP.T. Latexindo TobaperkasaK915548IONGUARD TITANIUM MODULAR HEADSBiomet, Inc.K903084MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc.K896580UNI-POLAR HEADRichards Medical Co., 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.

↑