Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K071074 |
Device Name |
MYKRES SPINAL SYSTEM |
Applicant |
SHOWA IKA KOHGYO CO.,LTD. |
11234 EL CAMINO REAL, SUITE 20 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
SHOWA IKA KOHGYO CO.,LTD. |
11234 EL CAMINO REAL, SUITE 20 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/16/2007 |
Decision Date | 07/02/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|