The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Optimus Alif System.
| Device ID | K160291 |
| 510k Number | K160291 |
| Device Name: | Optimus ALIF System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Amendia, Inc. 1755 West Oak Parkway Marietta, GA 30062 |
| Contact | Kristen Allen |
| Correspondent | Kristen Allen Amendia, Inc. 1755 West Oak Parkway Marietta, GA 30062 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-03 |
| Decision Date | 2016-02-18 |
| Summary: | summary |