Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
510(k) Number |
K000083 |
Device Name |
EBI XFIX DFS RAIL SYSTEM |
Applicant |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
JONAS WILF |
Correspondent |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
JONAS WILF |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 01/12/2000 |
Decision Date | 02/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|