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 |