Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K052385 |
Device Name |
TANGORS POLYAXIAL SYSTEM |
Applicant |
ULRICH GMBH & CO. KG |
BUCHBRUNNENWEG 12 |
ULM,
DE
D-89081
|
|
Applicant Contact |
CHRISTOPH ULRICH |
Correspondent |
ULRICH GMBH & CO. KG |
BUCHBRUNNENWEG 12 |
ULM,
DE
D-89081
|
|
Correspondent Contact |
CHRISTOPH ULRICH |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/30/2005 |
Decision Date | 12/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|