In2Bones Kirschner Wire

Pin, Fixation, Smooth

IN2BONES SAS

The following data is part of a premarket notification filed by In2bones Sas with the FDA for In2bones Kirschner Wire.

Pre-market Notification Details

• Device ID: K153204
• 510k Number: K153204
• Device Name: In2Bones Kirschner Wire
• Classification: Pin, Fixation, Smooth
• Applicant: IN2BONES SAS 28 CHEMIN DU PETIT BOIS Ecully, FR 69130
• Contact: Morgane Grenier
• Correspondent: Norman F Estrin; Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, MD 20854
• Product Code: HTY
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-04
• Decision Date: 2016-02-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760225717417	K153204	000
03760225714867	K153204	000
03760225714874	K153204	000
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