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FDA 510(k)

In2Bones Kirschner wire

K-Number: K153204 · 2016-02-01

ApplicantIn2bones Sas
Decision Date2016-02-01
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

In2Bones Kirschner wire is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2016-02-01 under 510(k) 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. The listed applicant is In2bones Sas. The 510(k) number is K153204.

When did In2Bones Kirschner wire receive FDA 510(k) clearance?

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

Who is the listed applicant for In2Bones Kirschner wire?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for In2Bones Kirschner wire?

The FDA product code for In2Bones Kirschner wire is HTY.

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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.

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