Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K012114 |
Device Name |
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM |
Applicant |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Applicant Contact |
MATTHEW M HULL |
Correspondent |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Correspondent Contact |
MATTHEW M HULL |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/06/2001 |
Decision Date | 09/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|