Device Classification Name |
Retractor, Self-Retaining, For Neurosurgery
|
510(k) Number |
K161680 |
Device Name |
MEDICON Spinal Spreading Systems |
Applicant |
MEDICON EG |
GANSACKER 15 |
TUTTLINGEN,
DE
78532
|
|
Applicant Contact |
Joachim Schmid |
Correspondent |
THE ORTHOMEDIX GROUP, INC |
1001 OAKWOOD BLVD |
ROUND ROCK,
TX
78681
|
|
Correspondent Contact |
J. D. Webb |
Regulation Number | 882.4800
|
Classification Product Code |
|
Date Received | 06/17/2016 |
Decision Date | 03/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|