Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K062317 |
Device Name |
MODIFICATION TO NUVASIVE SPHERX II SYSTEM |
Applicant |
NUVASIVE, INC. |
4545 TOWNE CENTRE COURT |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
LAETITIA COUSIN |
Correspondent |
NUVASIVE, INC. |
4545 TOWNE CENTRE COURT |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
LAETITIA COUSIN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/09/2006 |
Decision Date | 09/01/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|