The following data is part of a premarket notification filed by Medartis Ag with the FDA for Modus Trilock 2.0/2.3/2.5.
| Device ID | K071612 |
| 510k Number | K071612 |
| Device Name: | MODUS TRILOCK 2.0/2.3/2.5 |
| Classification | Plate, Bone |
| Applicant | MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Contact | Linda Schulz |
| Correspondent | Linda Schulz MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-13 |
| Decision Date | 2007-09-11 |
| Summary: | summary |