The following data is part of a premarket notification filed by Satyrne Medical with the FDA for Satyrne Interflex Mandibular Fixation System.
| Device ID | K072463 |
| 510k Number | K072463 |
| Device Name: | SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | SATYRNE MEDICAL 1909 GOLD AVE. SE # 1 Albuquerque, NM 87106 |
| Contact | Scott Lovald |
| Correspondent | Scott Lovald SATYRNE MEDICAL 1909 GOLD AVE. SE # 1 Albuquerque, NM 87106 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-31 |
| Decision Date | 2007-11-29 |
| Summary: | summary |