The following data is part of a premarket notification filed by Icotec Ag with the FDA for Kong-tl Vbr System, Kong-c Vbr System.
| Device ID | K200235 |
| 510k Number | K200235 |
| Device Name: | KONG-TL VBR System, KONG-C VBR System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | icotec Ag Industriestrasse 12 Altstaetten, CH 9450 |
| Contact | Marina Hess |
| Correspondent | Samuel Pollard MRCA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-30 |
| Decision Date | 2020-05-29 |