Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K070281 |
Device Name |
ISSYS LP SPINAL FIXATION SYSTEM |
Applicant |
CUSTOM SPINE, INC. |
13540 GUILD AVE |
APPLE VALLEY,
MN
55124
|
|
Applicant Contact |
RICHARD JANSEN |
Correspondent |
CUSTOM SPINE, INC. |
13540 GUILD AVE |
APPLE VALLEY,
MN
55124
|
|
Correspondent Contact |
RICHARD JANSEN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/29/2007 |
Decision Date | 06/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|