The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Spira-c Integrated Fixation System.
| Device ID | K193153 |
| 510k Number | K193153 |
| Device Name: | SPIRA-C Integrated Fixation System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Camber Spine Technologies 501 Allendale Road King Of Prussia, PA 19406 |
| Contact | Daniel Pontecorvo |
| Correspondent | Justin Eggleton Mcra, Llc 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2020-04-24 |