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)

CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT

K-Number: K033596 · 2004-05-10

ApplicantExactech, Inc.
Decision Date2004-05-10
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2004-05-10 under 510(k) number K033596. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT?

CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT is a medical device that received FDA 510(k) clearance on 2004-05-10. The listed applicant is Exactech, Inc.. The 510(k) number is K033596.

When did CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT receive FDA 510(k) clearance?

CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT received FDA 510(k) clearance on 2004-05-10, under 510(k) number K033596.

Who is the listed applicant for CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT?

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

What is the FDA product code for CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT?

The FDA product code for CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT is LOD.

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 Exactech, 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.

K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243448Equinoxe® Shoulder SystemK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee System

View all 169 devices →

Related Devices (Code: LOD)

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.

K254107Refobacin Bone Cement R (110034355)Biomet FranceK250760SPECTRUM GV Bone CementOsteoremedies, LLCK241674OSTEOPAL® VHeraeus Medical GmbHK231556SPECTRUM® GV Bone CementOsteoremedies, LLCK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda

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.

↑