Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K112085 |
Device Name |
SYNTHES LCP PEDIATRIC PLATE SYSTEMS |
Applicant |
SYNTHES (USA) PRODUCTS LLC |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
ANGELA F LASSANDRO |
Correspondent |
SYNTHES (USA) PRODUCTS LLC |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
ANGELA F LASSANDRO |
Regulation Number | 888.3030 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2011 |
Decision Date | 11/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|