APTUS ULNA PLATES

Plate, Fixation, Bone

MEDARTIS AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Ulna Plates.

Pre-market Notification Details

• Device ID: K103332
• 510k Number: K103332
• Device Name: APTUS ULNA PLATES
• Classification: Plate, Fixation, Bone
• Applicant: MEDARTIS AG 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130
• Contact: Kevin A Thomas
• Correspondent: Kevin A Thomas; MEDARTIS AG 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-12
• Decision Date: 2011-01-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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