FDA 510(k)

Flex-Thread Clavicle Pin System

K-Number: K163488 · 2017-03-20

Decision Date2017-03-20

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Flex-Thread Clavicle Pin System is a medical device manufactured by Intrafuse, LLC. It received FDA 510(k) clearance on 2017-03-20 under approval number K163488. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flex-Thread Clavicle Pin System?

Flex-Thread Clavicle Pin System is a medical device that received FDA 510(k) clearance on 2017-03-20. It is manufactured by Intrafuse, LLC. The 510(k) number is K163488.

When was Flex-Thread Clavicle Pin System approved by the FDA?

Flex-Thread Clavicle Pin System received FDA 510(k) clearance on 2017-03-20, under approval number K163488.

What company makes Flex-Thread Clavicle Pin System?

Flex-Thread Clavicle Pin System is manufactured by Intrafuse, LLC.

What is the FDA product code for Flex-Thread Clavicle Pin System?

The FDA product code for Flex-Thread Clavicle Pin System is HSB.

Other Devices by Intrafuse, LLC

K172943Flex-Thread Fibula Pin System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.