510(k) K211757
K211757 is an FDA 510(k) premarket notification submitted by Nuvasive, Inc. for the device "Simplify Disc". The FDA issued a decision of Substantially Equivalent on August 20, 2021. The device falls under product code QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices), a Class II device regulated under 21 CFR 888.4515. Nuvasive, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2021
- Date Received
- June 7, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device Class
- Class II
- Regulation Number
- 888.4515
- Review Panel
- OR
- Submission Type
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.