Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component, metal composite
|
510(k) Number |
K003205 |
Device Name |
TRANSFX ANGLED RODS |
Applicant |
IMMEDICA, INC. |
100 PASSAIC AVE. |
CHATHAM,
NJ
07928 -2848
|
|
Applicant Contact |
ROY BOGERT |
Correspondent |
IMMEDICA, INC. |
100 PASSAIC AVE. |
CHATHAM,
NJ
07928 -2848
|
|
Correspondent Contact |
ROY BOGERT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 10/13/2000 |
Decision Date | 12/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|