The following data is part of a premarket notification filed by Medartis Ag with the FDA for Modus 2.5 Mandibular Reconstruction Set.
| Device ID | K992682 |
| 510k Number | K992682 |
| Device Name: | MODUS 2.5 MANDIBULAR RECONSTRUCTION SET |
| Classification | Plate, Bone |
| Applicant | MEDARTIS AG 1601 TRAPELO RD. RESERVOIR PLACE Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert MEDARTIS AG 1601 TRAPELO RD. RESERVOIR PLACE Waltham, MA 02451 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-10 |
| Decision Date | 1999-11-24 |
| Summary: | summary |