Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K122738 |
Device Name |
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET |
Applicant |
SOLANA SURGICAL LLC |
6363 POPLAR AVE |
SUITE 434 |
MEMPHIS,
TN
38119
|
|
Applicant Contact |
REBECCA WAHL |
Correspondent |
SOLANA SURGICAL LLC |
6363 POPLAR AVE |
SUITE 434 |
MEMPHIS,
TN
38119
|
|
Correspondent Contact |
REBECCA WAHL |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/06/2012 |
Decision Date | 11/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|