FDA 510(k)

Flex-Thread Fibula Pin System

K-Number: K172943 · 2017-10-30

Decision Date2017-10-30

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Flex-Thread Fibula Pin System is a medical device manufactured by Intrafuse, LLC. It received FDA 510(k) clearance on 2017-10-30 under approval number K172943. 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 Fibula Pin System?

Flex-Thread Fibula Pin System is a medical device that received FDA 510(k) clearance on 2017-10-30. It is manufactured by Intrafuse, LLC. The 510(k) number is K172943.

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

Flex-Thread Fibula Pin System received FDA 510(k) clearance on 2017-10-30, under approval number K172943.

What company makes Flex-Thread Fibula Pin System?

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

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

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

Other Devices by Intrafuse, LLC

K163488Flex-Thread Clavicle Pin System

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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.