Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K141417 |
Device Name |
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
1023 CHERRY ROAD |
MEMPHIS,
TN
38117
|
|
Applicant Contact |
LESLIE FITCH |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
1023 CHERRY ROAD |
MEMPHIS,
TN
38117
|
|
Correspondent Contact |
LESLIE FITCH |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 05/29/2014 |
Decision Date | 07/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|