K211757 is an FDA 510(k) clearance for the Simplify Disc. This device is classified as a Manual Instruments Designed For Use With Total Disc Replacement Devices (Class II - Special Controls, product code QLQ).
Submitted by Nuvasive, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 20, 2021, 74 days after receiving the submission on June 7, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4515. The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices..
| 510(k) Number | K211757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2021 |
| Decision Date | August 20, 2021 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QLQ — Manual Instruments Designed For Use With Total Disc Replacement Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4515 |
| Definition | The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices. |