Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K161778 |
Device Name |
ToeTac™ 10° Hammertoe Fixation System |
Applicant |
RESTORE SURGICAL LLC DBA INSTRATEK |
15200 MIDDLEBROOK DR., SUITE G |
HOUSTON,
TX
77058
|
|
Applicant Contact |
JEFF SEAVEY |
Correspondent |
RESTORE SURGICAL LLC DBA INSTRATEK |
15200 MIDDLEBROOK DR., SUITE G |
HOUSTON,
TX
77058
|
|
Correspondent Contact |
JEFF SEAVEY |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/29/2016 |
Decision Date | 11/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|