Medical Device Manufacturer · US , North Attleboro , MA

Sodemsystems - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1994

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sodemsystems Neurology ✕

5 devices

1-5 of 5

Cleared Nov 25, 2002

DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)

Neurology · 70d

Cleared Oct 22, 2001

SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)

Neurology · 82d

Cleared Oct 22, 2001

SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)

Neurology · 82d

Cleared Dec 27, 1999

SODEM PERFORATOR DRIVE

Neurology · 45d

Cleared Dec 21, 1999

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

Neurology · 11d