NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP


Device Classification Name

orthopedic stereotaxic instrument

510(k) Number K122011
Device Name NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
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  
Date Received 07/09/2012
Decision Date 11/15/2012
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

Recalls CDRH Recalls