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 AND OSTEOGRAF/AR+

K-Number: K862324 · 1986-08-15

ApplicantCoors Biomedical Co.
Decision Date1986-08-15
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/AR AND OSTEOGRAF/AR+ 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 1986-08-15 under 510(k) number K862324. 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 AND OSTEOGRAF/AR+?

OSTEOGRAF/AR AND OSTEOGRAF/AR+ is a medical device that received FDA 510(k) clearance on 1986-08-15. The listed applicant is Coors Biomedical Co.. The 510(k) number is K862324.

When did OSTEOGRAF/AR AND OSTEOGRAF/AR+ receive FDA 510(k) clearance?

OSTEOGRAF/AR AND OSTEOGRAF/AR+ received FDA 510(k) clearance on 1986-08-15, under 510(k) number K862324.

Who is the listed applicant for OSTEOGRAF/AR AND OSTEOGRAF/AR+?

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 AND OSTEOGRAF/AR+?

The FDA product code for OSTEOGRAF/AR AND OSTEOGRAF/AR+ 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+K862061OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40K861084OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESHK861083OSTEOGRAF/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.

↑