APTUS FOOT 3.5 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 3.5 System.

Pre-market Notification Details

• Device ID: K110908
• 510k Number: K110908
• Device Name: APTUS FOOT 3.5 SYSTEM
• 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: 2011-03-31
• Decision Date: 2011-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630008436896	K110908	000
07630008436735	K110908	000
07630008436728	K110908	000
07630008436711	K110908	000
07630008436704	K110908	000
07630008436698	K110908	000
07630008436681	K110908	000
07630008436582	K110908	000
07630008436575	K110908	000
07630008436568	K110908	000
07630008436551	K110908	000
07630008436773	K110908	000
07630008436780	K110908	000
07630008436889	K110908	000
07630008436872	K110908	000
07630008436865	K110908	000
07630008436858	K110908	000
07630008436841	K110908	000
07630008436834	K110908	000
07630008436827	K110908	000
07630008436810	K110908	000
07630008436803	K110908	000
07630008436797	K110908	000
07630008436537	K110908	000
07630037896012	K110908	000
07630037885832	K110908	000
07630037885818	K110908	000
07630037885757	K110908	000
07630037885733	K110908	000
07630037885672	K110908	000
07630037885658	K110908	000
07630037885610	K110908	000
07630037885597	K110908	000
07630037885573	K110908	000
07630037885559	K110908	000
07630037886471	K110908	000
07630037886495	K110908	000
07630037896005	K110908	000
07630037886877	K110908	000
07630037886839	K110908	000
07630037886778	K110908	000
07630037886716	K110908	000
07630037886693	K110908	000
07630037886570	K110908	000
07630037886556	K110908	000
07630037886532	K110908	000
07630037886518	K110908	000
07630037885535	K110908	000
07630008436902	K110908	000
07630008437381	K110908	000
07630008437251	K110908	000
07630008437244	K110908	000
07630008437237	K110908	000
07630008437220	K110908	000
07630008437213	K110908	000
07630008437206	K110908	000
07630008437190	K110908	000
07630008437183	K110908	000
07630008437176	K110908	000
07630008437169	K110908	000
07630008437268	K110908	000
07630008437275	K110908	000
07630008437374	K110908	000
07630008437367	K110908	000
07630008437350	K110908	000
07630008437343	K110908	000
07630008437336	K110908	000
07630008437329	K110908	000
07630008437312	K110908	000
07630008437305	K110908	000
07630008437299	K110908	000
07630008437282	K110908	000
07630008437152	K110908	000
07630008437145	K110908	000
07630008437015	K110908	000
07630008437008	K110908	000
07630008436995	K110908	000
07630008436988	K110908	000
07630008436971	K110908	000
07630008436964	K110908	000
07630008436957	K110908	000
07630008436940	K110908	000
07630008436933	K110908	000
07630008436926	K110908	000
07630008437022	K110908	000
07630008437039	K110908	000
07630008437138	K110908	000
07630008437121	K110908	000
07630008437114	K110908	000
07630008437107	K110908	000
07630008437091	K110908	000
07630008437084	K110908	000
07630008437077	K110908	000
07630008437060	K110908	000
07630008437053	K110908	000
07630008437046	K110908	000
07630008436919	K110908	000