Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K033090 |
Device Name |
ICON POLYAXIAL PEDICLE SCREW SYSTEM |
Applicant |
ALPHATEC MFG., INC. |
6110 CORTE DEL CEDRO |
CARLSBAD,
CA
92009
|
|
Applicant Contact |
ELLEN A HICKS |
Correspondent |
ALPHATEC MFG., INC. |
6110 CORTE DEL CEDRO |
CARLSBAD,
CA
92009
|
|
Correspondent Contact |
ELLEN A HICKS |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/29/2003 |
Decision Date | 03/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|