Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K090477 |
Device Name |
ALPINE PEDICLE SCREW SYSTEM |
Applicant |
SANACOR |
PO BOX 1196 |
PLEASANT GROVE,
UT
84062
|
|
Applicant Contact |
MICHAEL ENSIGN |
Correspondent |
SANACOR |
PO BOX 1196 |
PLEASANT GROVE,
UT
84062
|
|
Correspondent Contact |
MICHAEL ENSIGN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/24/2009 |
Decision Date | 07/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|