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FDA 510(k)

OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40

K-Number: K862061 · 1986-07-29

ApplicantCoors Biomedical Co.
Decision Date1986-07-29
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 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 1986-07-29 under 510(k) number K862061. 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+ PERMARIDGE HYDROXYLAPATITE, 18-40?

OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 is a medical device that received FDA 510(k) clearance on 1986-07-29. The listed applicant is Coors Biomedical Co.. The 510(k) number is K862061.

When did OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 receive FDA 510(k) clearance?

OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 received FDA 510(k) clearance on 1986-07-29, under 510(k) number K862061.

Who is the listed applicant for OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40?

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+ PERMARIDGE HYDROXYLAPATITE, 18-40?

The FDA product code for OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 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.

K863176ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+K862324OSTEOGRAF/AR AND OSTEOGRAF/AR+K861084OSTEOGRAF/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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