Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K120157 |
Device Name |
MINI MAXLOCK EXTREME PLATING SYSTEM |
Applicant |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd. |
SUITE 500 |
Medina,
OH
44256
|
|
Applicant Contact |
DEREK LEWIS |
Correspondent |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd. |
SUITE 500 |
Medina,
OH
44256
|
|
Correspondent Contact |
DEREK LEWIS |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/18/2012 |
Decision Date | 04/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|