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
|
|
Correspondent Contact |
ALEXANDER SCHWIERSCH |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/24/2011 |
Decision Date | 08/05/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|