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FDA 510(k)

Synthetic Bone Graft Particulate

K-Number: K241186 · 2025-02-21

ApplicantShenzhen Dazhou Medical Technology Co., Ltd.
Decision Date2025-02-21
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Synthetic Bone Graft Particulate is a medical device manufactured by Shenzhen Dazhou Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-21 under approval number K241186. 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 Synthetic Bone Graft Particulate?

Synthetic Bone Graft Particulate is a medical device that received FDA 510(k) clearance on 2025-02-21. It is manufactured by Shenzhen Dazhou Medical Technology Co., Ltd.. The 510(k) number is K241186.

When was Synthetic Bone Graft Particulate approved by the FDA?

Synthetic Bone Graft Particulate received FDA 510(k) clearance on 2025-02-21, under approval number K241186.

What company makes Synthetic Bone Graft Particulate?

Synthetic Bone Graft Particulate is manufactured by Shenzhen Dazhou Medical Technology Co., Ltd..

What is the FDA product code for Synthetic Bone Graft Particulate?

The FDA product code for Synthetic Bone Graft Particulate is LYC.

Related Clinical Trials

NCT07225751 A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions. RECRUITING NCT07078331 Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations ACTIVE_NOT_RECRUITING NCT07492576 Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management RECRUITING

Other Devices by Shenzhen Dazhou Medical Technology Co., Ltd.

K241073DZ-Tabone Intervertebral Body Fusion Device

Related Devices (Code: LYC)

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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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