The following data is part of a premarket notification filed by Meditech Advisors, Llc with the FDA for Talos-c Cervical Intervertebral Body Fusion Devices.
| Device ID | K122850 |
| 510k Number | K122850 |
| Device Name: | TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDITECH ADVISORS, LLC 200 NOMER AVENUE Ashland, MA 01721 |
| Contact | Sharyn Orton |
| Correspondent | Sharyn Orton MEDITECH ADVISORS, LLC 200 NOMER AVENUE Ashland, MA 01721 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2013-03-28 |