Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K152974 |
Device Name |
ORTHOLOC® 3Di Foot Plating Reconstruction System |
Applicant |
Wright Medical Technology, Inc. |
1023 Cherry Road |
Memphis,
TN
38117
|
|
Applicant Contact |
Val Myles |
Correspondent |
Wright Medical Technology, Inc. |
1023 Cherry Road |
Memphis,
TN
38117
|
|
Correspondent Contact |
Val Myles |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 10/08/2015 |
Decision Date | 12/11/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|