Device Classification Name |
Pin, Fixation, Smooth
|
510(k) Number |
K970733 |
Device Name |
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
POST OFFICE BOX 1766 |
PAOLI,
PA
19301
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
POST OFFICE BOX 1766 |
PAOLI,
PA
19301
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/28/1997 |
Decision Date | 04/02/1997 |
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
|
|
|