Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Flex-Thread™ Ulna Intramedullary Nail System

K-Number: K222390 · 2022-11-21

Decision Date2022-11-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Flex-Thread™ Ulna Intramedullary Nail System is a medical device manufactured by Flower Orthopedics Corporation Dba Conventus Flower. It received FDA 510(k) clearance on 2022-11-21 under approval number K222390. 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™ Ulna Intramedullary Nail System?

Flex-Thread™ Ulna Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by Flower Orthopedics Corporation Dba Conventus Flower. The 510(k) number is K222390.

When was Flex-Thread™ Ulna Intramedullary Nail System approved by the FDA?

Flex-Thread™ Ulna Intramedullary Nail System received FDA 510(k) clearance on 2022-11-21, under approval number K222390.

What company makes Flex-Thread™ Ulna Intramedullary Nail System?

Flex-Thread™ Ulna Intramedullary Nail System is manufactured by Flower Orthopedics Corporation Dba Conventus Flower.

What is the FDA product code for Flex-Thread™ Ulna Intramedullary Nail System?

The FDA product code for Flex-Thread™ Ulna Intramedullary Nail System is HSB.

Related Clinical Trials

Other Devices by Flower Orthopedics Corporation Dba Conventus Flower

Related Devices (Code: HSB)

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.