The following data is part of a premarket notification filed by Medicon, Inc. with the FDA for Titanium Mandibular Fracture System.
| Device ID | K952168 |
| 510k Number | K952168 |
| Device Name: | TITANIUM MANDIBULAR FRACTURE SYSTEM |
| Classification | Plate, Bone |
| Applicant | MEDICON, INC. GANSACKER 15 D-78532/tuttlingen, DE |
| Contact | Sabine Hilsenbeck |
| Correspondent | Sabine Hilsenbeck MEDICON, INC. GANSACKER 15 D-78532/tuttlingen, DE |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-06-22 |