Device Classification Name |
dura substitute
|
510(k) Number |
K113071 |
Device Name |
SYNTHECEL DURA REPLACEMENT DEVICES |
Applicant |
SYNTHES |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
ANDREA M TASKER |
Correspondent |
SYNTHES |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
ANDREA M TASKER |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 10/17/2011 |
Decision Date | 01/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00859508
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|