The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Truespan Meniscal Repair System.
| Device ID | K153667 |
| 510k Number | K153667 |
| Device Name: | TRUESPAN Meniscal Repair System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel, CH 2400 |
| Contact | Kristine Christo |
| Correspondent | Yayoi Fujimaki Depuy Mitek, 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 | 2015-12-21 |
| Decision Date | 2016-03-24 |
| Summary: | summary |