The following data is part of a premarket notification filed by Carlsmed, Inc. with the FDA for Aprevo Intervertebral Body Fusion Device.
| Device ID | K202034 |
| 510k Number | K202034 |
| Device Name: | Aprevo Intervertebral Body Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Carlsmed, Inc. 4250 Executive Sq. Ste. 200 La Jolla, CA 92037 |
| Contact | Mike Cordonnier |
| Correspondent | Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-23 |
| Decision Date | 2020-12-03 |