Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
510(k) Number |
K071394 |
Device Name |
MODIFICATION TO:SBI RINGFIX |
Applicant |
SMALL BONE INNOVATIONS INC. |
505 PARK AVE., 14TH FLOOR |
NEW YORK,
NY
10022
|
|
Applicant Contact |
ROBERT HOEHN |
Correspondent |
SMALL BONE INNOVATIONS INC. |
505 PARK AVE., 14TH FLOOR |
NEW YORK,
NY
10022
|
|
Correspondent Contact |
ROBERT HOEHN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 05/21/2007 |
Decision Date | 06/29/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|