Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K073624 |
Device Name |
MODULAR FOOT SYSTEM |
Applicant |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1815 W. MARKET ST. |
SUITE 205 |
AKRON,
OH
44313
|
|
Applicant Contact |
DEREK LEWIS |
Correspondent |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1815 W. MARKET ST. |
SUITE 205 |
AKRON,
OH
44313
|
|
Correspondent Contact |
DEREK LEWIS |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 12/26/2007 |
Decision Date | 03/20/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|