The following data is part of a premarket notification filed by Amplify Surgical Inc with the FDA for Dualx Lumbar Intervertebral Body Fusion Device.
| Device ID | K192434 |
| 510k Number | K192434 |
| Device Name: | DualX Lumbar Intervertebral Body Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Amplify Surgical Inc 27071 Cabot Road, Suite 118 Laguna Hills, CA 82653 |
| Contact | Andy Choi |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-05 |
| Decision Date | 2019-10-15 |