The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Intrafix(tm) Advance Tibial Fastener System.
Device ID | K160804 |
510k Number | K160804 |
Device Name: | INTRAFIX(TM) Advance Tibial Fastener System |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38, CASE POSTALE Le Locle, CH Ch 2400 |
Contact | Kristine Christo |
Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-23 |
Decision Date | 2016-07-19 |
Summary: | summary |