Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K152062 |
Device Name |
BIOFOAM Bone Wedge |
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 |
|
Subsequent Product Code |
|
Date Received | 07/24/2015 |
Decision Date | 05/17/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|