Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K030625 |
Device Name |
SPINAL CONCEPTS INC. PATHFINDER |
Applicant |
SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F |
AUSTIN,
TX
78727
|
|
Applicant Contact |
LISA PERTERSON |
Correspondent |
SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F |
AUSTIN,
TX
78727
|
|
Correspondent Contact |
LISA PERTERSON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/27/2003 |
Decision Date | 03/28/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|