Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K160804 |
Device Name |
INTRAFIX(TM) Advance Tibial Fastener System |
Applicant |
MEDOS INTERNATIONAL SARL |
CHEMIN-BLANC 38, CASE POSTALE |
LE LOCLE,
CH
CH 2400
|
|
Applicant Contact |
KRISTINE CHRISTO |
Correspondent |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
KRISTINE CHRISTO |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/23/2016 |
Decision Date | 07/19/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|