The following data is part of a premarket notification filed by Icotec Ag with the FDA for Icotec Cervical Cage.
| Device ID | K192897 |
| 510k Number | K192897 |
| Device Name: | Icotec Cervical Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | icotec Ag Industriestrasse 12 9450 Altstaetten(sg), CH |
| Contact | Marina Hess |
| Correspondent | Justin Eggleton MCRA, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-11 |
| Decision Date | 2020-03-20 |