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FDA 510(k)

Nucleoss Tpure Implant System

K-Number: K160850 · 2017-08-04

ApplicantSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti
Decision Date2017-08-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nucleoss Tpure Implant System is a medical device manufactured by Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti. It received FDA 510(k) clearance on 2017-08-04 under approval number K160850. 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 Nucleoss Tpure Implant System?

Nucleoss Tpure Implant System is a medical device that received FDA 510(k) clearance on 2017-08-04. It is manufactured by Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti. The 510(k) number is K160850.

When was Nucleoss Tpure Implant System approved by the FDA?

Nucleoss Tpure Implant System received FDA 510(k) clearance on 2017-08-04, under approval number K160850.

What company makes Nucleoss Tpure Implant System?

Nucleoss Tpure Implant System is manufactured by Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti.

What is the FDA product code for Nucleoss Tpure Implant System?

The FDA product code for Nucleoss Tpure Implant System 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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