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FDA 510(k)

CeraRoot TL Implant System (TL)

K-Number: K242072 · 2025-05-14

ApplicantCeraroot SL
Decision Date2025-05-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CeraRoot TL Implant System (TL) is a medical device manufactured by Ceraroot SL. It received FDA 510(k) clearance on 2025-05-14 under approval number K242072. 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 CeraRoot TL Implant System (TL)?

CeraRoot TL Implant System (TL) is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Ceraroot SL. The 510(k) number is K242072.

When was CeraRoot TL Implant System (TL) approved by the FDA?

CeraRoot TL Implant System (TL) received FDA 510(k) clearance on 2025-05-14, under approval number K242072.

What company makes CeraRoot TL Implant System (TL)?

CeraRoot TL Implant System (TL) is manufactured by Ceraroot SL.

What is the FDA product code for CeraRoot TL Implant System (TL)?

The FDA product code for CeraRoot TL Implant System (TL) is DZE.

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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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