Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K121299 |
Device Name |
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD |
Applicant |
SAFE ORTHOPAEDICS |
Parc des Bellevues |
Allee R.Luxembourg-Bat Californie |
Eragny sur Oise,
FR
95610
|
|
Applicant Contact |
PIERRE DUMOUCHEL |
Correspondent |
SAFE ORTHOPAEDICS |
Parc des Bellevues |
Allee R.Luxembourg-Bat Californie |
Eragny sur Oise,
FR
95610
|
|
Correspondent Contact |
PIERRE DUMOUCHEL |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/30/2012 |
Decision Date | 07/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|