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FDA 510(k)

BONE PLUS BCP

K-Number: K090950 · 2010-07-02

ApplicantMegagen Implant Co., Ltd.
Decision Date2010-07-02
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE PLUS BCP is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2010-07-02 under 510(k) number K090950. 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 BONE PLUS BCP?

BONE PLUS BCP is a medical device that received FDA 510(k) clearance on 2010-07-02. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K090950.

When did BONE PLUS BCP receive FDA 510(k) clearance?

BONE PLUS BCP received FDA 510(k) clearance on 2010-07-02, under 510(k) number K090950.

Who is the listed applicant for BONE PLUS BCP?

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

What is the FDA product code for BONE PLUS BCP?

The FDA product code for BONE PLUS BCP is LYC.

Other records listing Megagen Implant Co., 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.

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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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