Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K121575 |
Device Name |
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM |
Applicant |
ORTHO SOLUTIONS LIMITED |
3150 EAST 200TH STREET |
PRIOR LAKE,
MN
55372
|
|
Applicant Contact |
AL LIPPINCOTT |
Correspondent |
ORTHO SOLUTIONS LIMITED |
3150 EAST 200TH STREET |
PRIOR LAKE,
MN
55372
|
|
Correspondent Contact |
AL LIPPINCOTT |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 05/30/2012 |
Decision Date | 09/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|