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 |