Device Classification Name |
spinal vertebral body replacement device - cervical
|
510(k) Number |
K151651 |
Device Name |
NuVasive X-CORE Mini Cervical Expandable VBR System |
Applicant |
NUVASIVE, INCORPORATED |
7475 LUSK BLVD. |
san diego,
CA
92121
|
|
Applicant Contact |
olga lewis |
Correspondent |
NUVASIVE, INCORPORATED |
7475 LUSK BLVD. |
san diego,
CA
92121
|
|
Correspondent Contact |
olga lewis |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 06/18/2015 |
Decision Date | 09/25/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|