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)

OSTEOPAL V

K-Number: K050085 · 2005-09-14

ApplicantHeraeus Kulzer,GmbH
Decision Date2005-09-14
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOPAL V is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer,GmbH. It received FDA 510(k) clearance on 2005-09-14 under 510(k) number K050085. 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 OSTEOPAL V?

OSTEOPAL V is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is Heraeus Kulzer,GmbH. The 510(k) number is K050085.

When did OSTEOPAL V receive FDA 510(k) clearance?

OSTEOPAL V received FDA 510(k) clearance on 2005-09-14, under 510(k) number K050085.

Who is the listed applicant for OSTEOPAL V?

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

What is the FDA product code for OSTEOPAL V?

The FDA product code for OSTEOPAL V 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 Heraeus Kulzer,GmbH 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.

K083652IBOND TOTAL ETCHK080338CUTTERSIL ACTIVATOR UNIVERSAL PLUSK073554NEUNK062515RETENTION FLOW OPAQUEK050855PALAMED GK050854PALACOS LV+G

View all 10 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.

↑