Device Classification Name |
Cerclage, Fixation
|
510(k) Number |
K010943 |
Device Name |
SYNTHES STERNAL FIXATION 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 | 888.3010
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/29/2001 |
Decision Date | 06/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|