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FDA 510(k)

CORE1 Implant System

K-Number: K210039 · 2022-01-07

ApplicantCybermed, Inc.
Decision Date2022-01-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORE1 Implant System is a medical device manufactured by Cybermed, Inc.. It received FDA 510(k) clearance on 2022-01-07 under approval number K210039. 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 CORE1 Implant System?

CORE1 Implant System is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Cybermed, Inc.. The 510(k) number is K210039.

When was CORE1 Implant System approved by the FDA?

CORE1 Implant System received FDA 510(k) clearance on 2022-01-07, under approval number K210039.

What company makes CORE1 Implant System?

CORE1 Implant System is manufactured by Cybermed, Inc..

What is the FDA product code for CORE1 Implant System?

The FDA product code for CORE1 Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

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) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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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