Device Classification Name |
Appliance, Fixation, Spinal Interlaminal
|
510(k) Number |
K934007 |
Device Name |
SOFAMOR ORFIL SPINE FIXATION SYSTEM |
Applicant |
SOFAMOR CO. |
158 RUE DE L'ENGLISE |
B.P. 4 RANG-DU-FLIERS 62180 |
FRANCE,
FR
|
|
Applicant Contact |
BRIAN GOODEN |
Correspondent |
SOFAMOR CO. |
158 RUE DE L'ENGLISE |
B.P. 4 RANG-DU-FLIERS 62180 |
FRANCE,
FR
|
|
Correspondent Contact |
BRIAN GOODEN |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 08/18/1993 |
Decision Date | 06/02/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|