Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K123203 |
Device Name |
MAXLOCK EXTREME SYSTEM MODEL MXL |
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 | 10/12/2012 |
Decision Date | 12/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|