The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Amendia Interbody Fusion Devices.
| Device ID | K151310 |
| 510k Number | K151310 |
| Device Name: | Amendia Interbody Fusion Devices |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | AMENDIA, INC. 1755 WEST OAK PARKWAY Marietta, GA 30062 |
| Contact | Bruce Hooper |
| Correspondent | Kristen Allen AMENDIA, INC. 1755 WEST OAK PARKWAY Marietta, GA 30062 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2016-01-06 |
| Summary: | summary |