Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K131324 |
Device Name |
MAXTORQUE SCREW SYSTEM |
Applicant |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd. |
SUITE 500 |
Medina,
OH
44256
|
|
Applicant Contact |
BRIAN HOCKETT |
Correspondent |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd. |
SUITE 500 |
Medina,
OH
44256
|
|
Correspondent Contact |
BRIAN HOCKETT |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/08/2013 |
Decision Date | 05/31/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|