The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Speedtrap Graft Preparation System.
| Device ID | K161638 |
| 510k Number | K161638 |
| Device Name: | SPEEDTRAP Graft Preparation System |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38 Le Locle Neuchatel, CH 2400 |
| Contact | Jeffrey Dzialo |
| Correspondent | Jeffrey Dzialo DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 PARAMOUNT DR Raynham, MA 02767 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-14 |
| Decision Date | 2016-11-07 |
| Summary: | summary |