Device Classification Name |
Mesh, Surgical, Metal
|
510(k) Number |
K020853 |
Device Name |
NUVASIVE MESH |
Applicant |
NUVASIVE, INC. |
10065 OLD GROVE RD. |
SAN DIEGO,
CA
92131
|
|
Applicant Contact |
LAETITIA BERNARD |
Correspondent |
NUVASIVE, INC. |
10065 OLD GROVE RD. |
SAN DIEGO,
CA
92131
|
|
Correspondent Contact |
LAETITIA BERNARD |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/15/2002 |
Decision Date | 06/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|