FDA 510(k)

FG Bone Graft M

K-Number: K244006 · 2025-09-17

Decision Date2025-09-17

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FG Bone Graft M is the device name listed in this FDA 510(k) record. The listed applicant is Full Golden Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K244006. 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 FG Bone Graft M?

FG Bone Graft M is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Full Golden Biotech Co., Ltd.. The 510(k) number is K244006.

When did FG Bone Graft M receive FDA 510(k) clearance?

FG Bone Graft M received FDA 510(k) clearance on 2025-09-17, under 510(k) number K244006.

Who is the listed applicant for FG Bone Graft M?

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

What is the FDA product code for FG Bone Graft M?

The FDA product code for FG Bone Graft M is LYC.

Other records listing Full Golden Biotech 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.

K243745FG Bone Graft B

Related Devices (Code: LYC)

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K243745FG Bone Graft BFull Golden Biotech Corporation K241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.K213260CMFlexTMDimension Inx Corp.

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.