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FDA 510(k)

CuffLink Implant System Biocomposite

K-Number: K180763 · 2018-07-19

ApplicantConmed Corporation
Decision Date2018-07-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CuffLink Implant System Biocomposite is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2018-07-19 under approval number K180763. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CuffLink Implant System Biocomposite?

CuffLink Implant System Biocomposite is a medical device that received FDA 510(k) clearance on 2018-07-19. It is manufactured by Conmed Corporation. The 510(k) number is K180763.

When was CuffLink Implant System Biocomposite approved by the FDA?

CuffLink Implant System Biocomposite received FDA 510(k) clearance on 2018-07-19, under approval number K180763.

What company makes CuffLink Implant System Biocomposite?

CuffLink Implant System Biocomposite is manufactured by Conmed Corporation.

What is the FDA product code for CuffLink Implant System Biocomposite?

The FDA product code for CuffLink Implant System Biocomposite is MAI.

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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)

Other Devices by Conmed Corporation

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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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