Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K000766 |
Device Name |
TRI-FIX SPINAL FIXATION SYSTEM |
Applicant |
ENDIUS, INC. |
23 WEST BACON ST. |
PLAINVILLE,
MA
02762
|
|
Applicant Contact |
SUSAN FINNERAN |
Correspondent |
ENDIUS, INC. |
23 WEST BACON ST. |
PLAINVILLE,
MA
02762
|
|
Correspondent Contact |
SUSAN FINNERAN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/09/2000 |
Decision Date | 06/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|