Device Classification Name |
Nail, Fixation, Bone
|
510(k) Number |
K040762 |
Device Name |
SYNTHES (USA) TIBIAL NAIL SYSTEM EX |
Applicant |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
SYNTHES (USA) |
P.O. BOX 1766 |
1690 RUSSELL ROAD |
PAOLI,
PA
19301 -1222
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 03/25/2004 |
Decision Date | 04/12/2004 |
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
|
|
|