The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Amendia Stand-alone Cervical System.
| Device ID | K152972 |
| 510k Number | K152972 |
| Device Name: | Amendia Stand-Alone Cervical System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| 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 | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-08 |
| Decision Date | 2016-01-14 |
| Summary: | summary |