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FDA 510(k)

SNUCONE Bone Level Implant System

K-Number: K210354 · 2022-07-13

ApplicantSnucone Co., Ltd.
Decision Date2022-07-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SNUCONE Bone Level Implant System is a medical device manufactured by Snucone Co., Ltd.. It received FDA 510(k) clearance on 2022-07-13 under approval number K210354. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNUCONE Bone Level Implant System?

SNUCONE Bone Level Implant System is a medical device that received FDA 510(k) clearance on 2022-07-13. It is manufactured by Snucone Co., Ltd.. The 510(k) number is K210354.

When was SNUCONE Bone Level Implant System approved by the FDA?

SNUCONE Bone Level Implant System received FDA 510(k) clearance on 2022-07-13, under approval number K210354.

What company makes SNUCONE Bone Level Implant System?

SNUCONE Bone Level Implant System is manufactured by Snucone Co., Ltd..

What is the FDA product code for SNUCONE Bone Level Implant System?

The FDA product code for SNUCONE Bone Level Implant System is DZE.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Snucone Co., Ltd.

K222792SNUCONE Tissue Level Implant System

Related Devices (Code: DZE)

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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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