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 |