Device Classification Name |
component, traction, invasive |
|||
---|---|---|---|---|
510(k) Number | K022065 | |||
Device Name | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | |||
Original Applicant |
|
|||
Original Contact | marianne grunwaldt | |||
Regulation Number | 888.3040 | |||
Classification Product Code |
|
|||
Date Received | 06/25/2002 | |||
Decision Date | 08/06/2002 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Orthopedic |
|||
510k Review Panel |
Orthopedic |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |