The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Milagro Advance Peek Interference Screw.
Device ID | K161001 |
510k Number | K161001 |
Device Name: | MILAGRO ADVANCE PEEK Interference Screw |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38, CASE POSTALE Le Locle, CH Ch 2400 |
Contact | Kristine Christo |
Correspondent | Kristine Christo DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-11 |
Decision Date | 2016-06-09 |
Summary: | summary |