Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K111678 |
Device Name |
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS 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 | 06/15/2011 |
Decision Date | 02/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|