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FDA 510(k)

BOND APATITE

K-Number: K121177 · 2013-12-05

ApplicantAugma Biomaterials, Ltd.
Decision Date2013-12-05
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOND APATITE is the device name listed in this FDA 510(k) record. The listed applicant is Augma Biomaterials, Ltd.. It received FDA 510(k) clearance on 2013-12-05 under 510(k) number K121177. 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 BOND APATITE?

BOND APATITE is a medical device that received FDA 510(k) clearance on 2013-12-05. The listed applicant is Augma Biomaterials, Ltd.. The 510(k) number is K121177.

When did BOND APATITE receive FDA 510(k) clearance?

BOND APATITE received FDA 510(k) clearance on 2013-12-05, under 510(k) number K121177.

Who is the listed applicant for BOND APATITE?

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

What is the FDA product code for BOND APATITE?

The FDA product code for BOND APATITE is LYC.

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Other records listing Augma Biomaterials, 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.

K083858BOND BONE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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