The following data is part of a premarket notification filed by Kyocera Medical Technologies, Inc. with the FDA for Kmti Tesera Sa Anterior Lumbar Interbody Fusion (alif) System.
| Device ID | K193320 |
| 510k Number | K193320 |
| Device Name: | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Kyocera Medical Technologies, Inc. 1200 California St, Suite 210 Redlands, CA 92374 |
| Contact | Anthony Debenedictis |
| Correspondent | Sharyn Orton MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-02-04 |