Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K112406 |
Device Name |
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES |
Applicant |
SMITH & NEPHEW, INC. |
7135 GOODLET FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Applicant Contact |
DAVID HENLY |
Correspondent |
SMITH & NEPHEW, INC. |
7135 GOODLET FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Correspondent Contact |
DAVID HENLY |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/22/2011 |
Decision Date | 11/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|