Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K122742 |
Device Name |
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM |
Applicant |
NUVASIVE, INC. |
7475 LUSK BLVD |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
Sheila Bruschi |
Correspondent |
NUVASIVE, INC. |
7475 LUSK BLVD |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
Sheila Bruschi |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 09/07/2012 |
Decision Date | 12/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|