Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K102156 |
Device Name |
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS |
Applicant |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 MEDINA ROAD |
SUITE 500 |
MEDINA,
OH
44256
|
|
Applicant Contact |
DEREK LEWIS |
Correspondent |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 MEDINA ROAD |
SUITE 500 |
MEDINA,
OH
44256
|
|
Correspondent Contact |
DEREK LEWIS |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/30/2010 |
Decision Date | 09/30/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|