Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K113006 |
Device Name |
I-FUSE HAMMER TOE SYSTEMS |
Applicant |
ORTHOPRO LLC |
1001 OAKWOOD BLVD. |
ROUND ROCK,
TX
78681
|
|
Applicant Contact |
J D WEBB |
Correspondent |
ORTHOPRO LLC |
1001 OAKWOOD BLVD. |
ROUND ROCK,
TX
78681
|
|
Correspondent Contact |
J D WEBB |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 10/07/2011 |
Decision Date | 05/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|