Device Classification Name |
screw, fixation, bone |
|||
---|---|---|---|---|
510(k) Number | K992367 | |||
Device Name | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS | |||
Applicant |
|
|||
Applicant Contact | jonas wilf | |||
Correspondent |
|
|||
Correspodent Contact | jonas wilf | |||
Regulation Number | 888.3040 | |||
Classification Product Code |
|
|||
Date Received | 07/15/1999 | |||
Decision Date | 09/23/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Orthopedic |
|||
510k Review Panel |
Orthopedic |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |