Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K092287 |
Device Name |
NUVASIVE SPHERX II - PEDICLE SCREW 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 | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/29/2009 |
Decision Date | 10/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|