DISTAL VOLAR RADIUS PLATING SYSTEMS


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component, metal composite

510(k) Number K112345
Device Name DISTAL VOLAR RADIUS PLATING SYSTEMS
Applicant
MEDOS INTERNATIONAL SARL
700 orthopaedic drive
warsaw, 
IN 
46581

Applicant Contact suzana otano
Correspondent
MEDOS INTERNATIONAL SARL
700 orthopaedic drive
warsaw, 
IN 
46581

Correspodent Contact suzana otano
Regulation Number 888.3030
Classification Product Code
LXT  
Date Received 08/15/2011
Decision Date 10/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls