The following data is part of a premarket notification filed by Optik with the FDA for Titamed Antwerp System.
| Device ID | K896404 |
| 510k Number | K896404 |
| Device Name: | TITAMED ANTWERP SYSTEM |
| Classification | Plate, Bone |
| Applicant | OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Contact | William M Macfie |
| Correspondent | William M Macfie OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-07 |
| Decision Date | 1990-04-16 |