Device Classification Name |
spinal vertebral body replacement device
|
510(k) Number |
K032476 |
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 | 888.3060
|
Classification Product Code |
|
Date Received | 08/12/2003 |
Decision Date | 11/13/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|