The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Simplify Disc.
| Device ID | K211757 |
| 510k Number | K211757 |
| Device Name: | Simplify Disc |
| Classification | Manual Instruments Designed For Use With Total Disc Replacement Devices |
| Applicant | NuVasive, Inc. 685 North Pastoria Avenue Sunnyvale, CA 94085 |
| Contact | Beth Neil |
| Correspondent | Justin Eggleton MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | QLQ |
| CFR Regulation Number | 888.4515 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-07 |
| Decision Date | 2021-08-20 |