Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K981372 |
Device Name |
SYNTHES 3.0 MM PC-FIX SYSTEM |
Applicant |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Applicant Contact |
ANGELA J SILVESTRI |
Correspondent |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Correspondent Contact |
ANGELA J SILVESTRI |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/16/1998 |
Decision Date | 05/11/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|