Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: OsteoCool™ RF Ablation System, CD Horizon™ ModuLeX™ Fenestrated Screw Set, Infinity™ OCT System
171
Total
160
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Sofamor Danek USA, Inc. Dental ✕
6 devices
Cleared
Jun 10, 2014
MASTERGRAFT PUTTY
Dental
116d
Cleared
May 30, 2012
ARTISAN SPACE MAINTENANCE SYSTEM
Dental
121d
Cleared
Apr 13, 2011
ARCHITEX SPACE MAINTENANCE SYSTEM
Dental
75d
Cleared
Dec 13, 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
Dental
269d
Cleared
Dec 30, 2009
MEDTRONIC DENTAL TCP
Dental
174d
Cleared
Jun 05, 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
Dental
89d