Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K052151 |
Device Name |
SYNTHES PANGEA MONOAXIAL SYSTEM |
Applicant |
SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
ANGELA MIKROULIS |
Correspondent |
SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
ANGELA MIKROULIS |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/08/2005 |
Decision Date | 12/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|