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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 the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2018-07-19 under 510(k) 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. The listed applicant is Conmed Corporation. The 510(k) number is K180763.

When did CuffLink Implant System Biocomposite receive FDA 510(k) clearance?

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

Who is the listed applicant for CuffLink Implant System Biocomposite?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Conmed Corporation as applicant

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Related Devices (Code: MAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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