The following data is part of a premarket notification filed by Medartis Ag with the FDA for Modus 2.5 Mandibular Trauma Set.
Device ID | K992683 |
510k Number | K992683 |
Device Name: | MODUS 2.5 MANDIBULAR TRAUMA 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 |