The following data is part of a premarket notification filed by Keos with the FDA for Keos Lumbar Ibfd.
| Device ID | K163386 |
| 510k Number | K163386 |
| Device Name: | Keos Lumbar IBFD |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Keos 1824 Colonial Village Lane Lancaster, PA 17601 |
| Contact | Mark F Schenk |
| Correspondent | Mark F Schenk Keos 1824 Colonial Village Lane Lancaster, PA 17601 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-02 |
| Decision Date | 2017-04-10 |
| Summary: | summary |