Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K031178 |
Device Name |
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Applicant Contact |
LISA M BOYLE |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Correspondent Contact |
LISA M BOYLE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/14/2003 |
Decision Date | 05/05/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|