Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K081377 |
Device Name |
NUVASIVE SURGICAL MESH SYSTEM |
Applicant |
NUVASIVE, INC. |
7475 LUSK BLVD |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
LAETITIA COUSIN |
Correspondent |
NUVASIVE, INC. |
7475 LUSK BLVD |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
LAETITIA COUSIN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/16/2008 |
Decision Date | 01/15/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|