Device Classification Name |
Orthosis, Spondylolisthesis Spinal Fixation
|
510(k) Number |
K001627 |
Device Name |
TRIFIX 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 | 05/26/2000 |
Decision Date | 06/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|