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)

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD

K-Number: K954768 · 1996-01-18

ApplicantBiologically Oriented Prostheses
Decision Date1996-01-18
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Biologically Oriented Prostheses. It received FDA 510(k) clearance on 1996-01-18 under 510(k) number K954768. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD?

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD is a medical device that received FDA 510(k) clearance on 1996-01-18. The listed applicant is Biologically Oriented Prostheses. The 510(k) number is K954768.

When did BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD receive FDA 510(k) clearance?

BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD received FDA 510(k) clearance on 1996-01-18, under 510(k) number K954768.

Who is the listed applicant for BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD?

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

What is the FDA product code for BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD?

The FDA product code for BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD is LZO.

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 Biologically Oriented Prostheses 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.

K002325WUJIN #3 TIBIAL NAILK992144BIOPRO RIMMED ACETABULAR COMPOMENTK964472RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTK962769HORIZON HIP SYSTEMK955916TOWNLEY TOTAL ELBOW SYSTEMK952731TOWNLEY ALL POLY ACETABULAR CUP

View all 9 devices →

Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast 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.

↑