Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K111136 |
Device Name |
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM |
Applicant |
DEPUY SPINE, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
FRANK JURCZAK |
Correspondent |
DEPUY SPINE, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
FRANK JURCZAK |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/22/2011 |
Decision Date | 06/14/2012 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|