FDA 510(k)

In2Bones Kirschner wire

K-Number: K153204 · 2016-02-01

Decision Date2016-02-01

Product CodeHTY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

In2Bones Kirschner wire is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2016-02-01 under approval number K153204. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the In2Bones Kirschner wire?

In2Bones Kirschner wire is a medical device that received FDA 510(k) clearance on 2016-02-01. It is manufactured by In2bones Sas. The 510(k) number is K153204.

When was In2Bones Kirschner wire approved by the FDA?

In2Bones Kirschner wire received FDA 510(k) clearance on 2016-02-01, under approval number K153204.

What company makes In2Bones Kirschner wire?

In2Bones Kirschner wire is manufactured by In2bones Sas.

What is the FDA product code for In2Bones Kirschner wire?

The FDA product code for In2Bones Kirschner wire is HTY.

Other Devices by In2bones Sas

K160174I.B.S. 2.0 Osteosynthesis screw K160995NEOVIEW Plating System K153770OS2(R)-VP Varisation Staple K153395OS2-C Compression Staple K170688PITStop® implant K173121Ankle Fusion Plating System

View all 14 devices →

Related Devices (Code: HTY)

K161489Syntorr K-wire and Pin SystemSyntorr, Inc. K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC K160194StarFuse Interphalangeal PinPhalanx Innovations K152662S-WireSpinal Resources, Inc. K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc. K173013WishBone K-Wire SystemWishbone Medical, Inc.

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.