APTUS FOOT SYSTEM

Plate, Fixation, Bone

MEDARTIS AG

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

Pre-market Notification Details

• Device ID: K091479
• 510k Number: K091479
• Device Name: APTUS FOOT SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130
• Contact: Linda Schulz
• Correspondent: Linda Schulz; MEDARTIS AG 11234 EL CAMINO REAL, STE 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: 2009-05-19
• Decision Date: 2009-07-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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