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)

FORTOSS VITAL BONE GRAFT SUBSTITUTE

K-Number: K050170 · 2005-08-26

ApplicantBiocomposites, Ltd.
Decision Date2005-08-26
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FORTOSS VITAL BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2005-08-26 under 510(k) number K050170. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTOSS VITAL BONE GRAFT SUBSTITUTE?

FORTOSS VITAL BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2005-08-26. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K050170.

When did FORTOSS VITAL BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

FORTOSS VITAL BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2005-08-26, under 510(k) number K050170.

Who is the listed applicant for FORTOSS VITAL BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for FORTOSS VITAL BONE GRAFT SUBSTITUTE?

The FDA product code for FORTOSS VITAL BONE GRAFT SUBSTITUTE is LYC.

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 Biocomposites, Ltd. 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.

K251680Biosteon® ScrewK242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerK250521NanoBone® SBX Putty ; NanoBone® QDK212721Genex Bone Graft SubstituteK082381GENEXK082383FORTOSS VITAL

View all 26 devices →

Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

↑