The following data is part of a premarket notification filed by Meditech Advisors, Llc with the FDA for Talos Intervertebral Body Fusion Device.
| Device ID | K090707 |
| 510k Number | K090707 |
| Device Name: | TALOS INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDITECH ADVISORS, LLC 950 N. MICHIGAN AVE. SUITE 2202 Chicago, IL 60611 |
| Contact | Janet M Webb |
| Correspondent | Janet M Webb MEDITECH ADVISORS, LLC 950 N. MICHIGAN AVE. SUITE 2202 Chicago, IL 60611 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-17 |
| Decision Date | 2009-07-15 |
| Summary: | summary |