Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K040096 |
Device Name |
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM |
Applicant |
SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F |
AUSTIN,
TX
78727
|
|
Applicant Contact |
LISA PETERSON |
Correspondent |
SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F |
AUSTIN,
TX
78727
|
|
Correspondent Contact |
LISA PETERSON |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 01/20/2004 |
Decision Date | 07/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|