FDA 510(k)

Flex-Thread Distal Fibula lntramedullary Nail System

K-Number: K212030 · 2021-07-23

ApplicantFlower Orthopedics Corporation Dba Conventus Flower

Decision Date2021-07-23

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Flex-Thread Distal Fibula lntramedullary Nail System is a medical device manufactured by Flower Orthopedics Corporation Dba Conventus Flower. It received FDA 510(k) clearance on 2021-07-23 under approval number K212030. 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 Distal Fibula lntramedullary Nail System?

Flex-Thread Distal Fibula lntramedullary Nail System is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Flower Orthopedics Corporation Dba Conventus Flower. The 510(k) number is K212030.

When was Flex-Thread Distal Fibula lntramedullary Nail System approved by the FDA?

Flex-Thread Distal Fibula lntramedullary Nail System received FDA 510(k) clearance on 2021-07-23, under approval number K212030.

What company makes Flex-Thread Distal Fibula lntramedullary Nail System?

Flex-Thread Distal Fibula lntramedullary Nail System is manufactured by Flower Orthopedics Corporation Dba Conventus Flower.

What is the FDA product code for Flex-Thread Distal Fibula lntramedullary Nail System?

The FDA product code for Flex-Thread Distal Fibula lntramedullary Nail System is HSB.

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Other Devices by Flower Orthopedics Corporation Dba Conventus Flower

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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.