The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Nexgen Standalone Anterior Cervical Discectomy And Fusion (acdf) System.
| Device ID | K203129 |
| 510k Number | K203129 |
| Device Name: | NexGen Standalone Anterior Cervical Discectomy And Fusion (ACDF) System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
| Contact | Michael Dawson |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-19 |
| Decision Date | 2021-01-12 |
| Summary: | summary |