The following data is part of a premarket notification filed by Icotec Ag with the FDA for Icotec Anterior Cervical Plate System.
| Device ID | K201587 |
| 510k Number | K201587 |
| Device Name: | Icotec Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Icotec AG Industriestrasse 12 Altstaetten, CH 9450 |
| Contact | Marina Hess |
| Correspondent | Margeaux Rogers Mcra, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2020-10-15 |