UNI-KNEE 2.0


Device Classification Name

neurological stereotaxic instrument

510(k) Number K080678
Device Name UNI-KNEE 2.0
Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Applicant Contact per persson
Correspondent
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Correspodent Contact per persson
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 03/10/2008
Decision Date 06/06/2008
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