BRAINLAB TRAUMA


Device Classification Name

orthopedic stereotaxic instrument

510(k) Number K110204
Device Name BRAINLAB TRAUMA
Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Applicant Contact alexander schwiersch
Correspondent
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Correspodent Contact alexander schwiersch
Regulation Number 882.4560
Classification Product Code
OLO  
Subsequent Product Code
HAW  
Date Received 01/24/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No