510(k) Premarket Notification Database
Device Classification Name |
screw, fixation, bone
|
510(k) Number | K063635 |
Device Name | SBI FOREFOOT SET |
Applicant |
SMALL BONE INNOVATIONS, INC.
|
505 park avenue |
14th floor |
new york,
NY
10022 |
|
Contact | robert hoehn |
Regulation Number | 888.3040 |
Classification Product Code |
|
Date Received | 12/06/2006 |
Decision Date | 08/29/2007 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Orthopedic
|
Review Advisory Committee |
Orthopedic
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|