Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K120360 |
Device Name |
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS |
Applicant |
ORTHO SOLUTIONS LIMITED |
3150 E. 200TH STREET |
PRIOR LAKE,
MN
55372
|
|
Applicant Contact |
AL LIPPINCOTT |
Correspondent |
ORTHO SOLUTIONS LIMITED |
3150 E. 200TH STREET |
PRIOR LAKE,
MN
55372
|
|
Correspondent Contact |
AL LIPPINCOTT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/06/2012 |
Decision Date | 05/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|