The following data is part of a premarket notification filed by Keos with the FDA for Keos Lumbar Ibfd.
| Device ID | K193174 |
| 510k Number | K193174 |
| Device Name: | Keos Lumbar IBFD |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Keos 1824 Colonial Village Lane Lancaster, PA 17601 |
| Contact | Scott Peterson |
| Correspondent | Maris Garner MRC-X, LLC 6075 Poplar Ave. Memphis, TN 38119 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2019-12-16 |