Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K003527 |
Device Name |
MODIFICATION TO SYNTHES (USA) POLYPIN |
Applicant |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Applicant Contact |
THOMAS M MAGUIRE |
Correspondent |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Correspondent Contact |
THOMAS M MAGUIRE |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 11/16/2000 |
Decision Date | 04/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|