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)

OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH

K-Number: K861084 · 1986-04-30

ApplicantCoors Biomedical Co.
Decision Date1986-04-30
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH is the device name listed in this FDA 510(k) record. The listed applicant is Coors Biomedical Co.. It received FDA 510(k) clearance on 1986-04-30 under 510(k) number K861084. 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 OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH?

OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Coors Biomedical Co.. The 510(k) number is K861084.

When did OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH receive FDA 510(k) clearance?

OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH received FDA 510(k) clearance on 1986-04-30, under 510(k) number K861084.

Who is the listed applicant for OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH?

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

What is the FDA product code for OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH?

The FDA product code for OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH 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 Coors Biomedical Co. 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.

K863176ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+K862324OSTEOGRAF/AR AND OSTEOGRAF/AR+K862061OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40K861083OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESHK852742OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40K810822DENTAL PORCELAIN POWDER

View all 7 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.

↑