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FDA 510(k)

ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+

K-Number: K863176 · 1986-11-26

ApplicantCoors Biomedical Co.
Decision Date1986-11-26
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent for Some Indications

Device Summary

ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & 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 1986-11-26 under 510(k) number K863176. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+?

ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ is a medical device that received FDA 510(k) clearance on 1986-11-26. The listed applicant is Coors Biomedical Co.. The 510(k) number is K863176.

When did ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ receive FDA 510(k) clearance?

ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ received FDA 510(k) clearance on 1986-11-26, under 510(k) number K863176.

Who is the listed applicant for ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & 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 ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+?

The FDA product code for ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ is LYC.

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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.

K862324OSTEOGRAF/AR AND OSTEOGRAF/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

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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.

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