The following data is part of a premarket notification filed by Tekka with the FDA for Ortrautek Orthognathic System.
| Device ID | K031989 |
| 510k Number | K031989 |
| Device Name: | ORTRAUTEK ORTHOGNATHIC SYSTEM |
| Classification | Plate, Bone |
| Applicant | TEKKA 6512 BANNOCKBURN DRIVE Bethesda, MD 20817 |
| Contact | Fayyaz Memon |
| Correspondent | Fayyaz Memon TEKKA 6512 BANNOCKBURN DRIVE Bethesda, MD 20817 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2003-10-28 |
| Summary: | summary |