Simplify Cervical Artificial Disc
FDA premarket approval P200022/S015 · decided 2025-02-13
Approval details
- PMA number
- P200022
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Simplify Cervical Artificial Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Nuvasive, Inc.
- Date received
- 2025-01-16
- Decision date
- 2025-02-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- a change to the mid-process inspection method and strategy, updates to the MicroVu programs for measurement of endplate features, and a change to a mid-process quality control step to assess cleat height using MicroVu probes rather than camera-vision
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NuVasive AttraX Scaffold (K240507) | Nuvasive, Inc. | 2024-03-20 |
| NuVasive Modulus-C Interbody System (K223731) | Nuvasive, Inc. | 2023-01-12 |
| Simplify Disc (K211757) | Nuvasive, Inc. | 2021-08-20 |
| NuVasive® VersaTie™ System (K173117) | Nuvasive, Inc. | 2017-12-07 |
| NuVasive CoRoent System (K141665) | Nuvasive, Inc. | 2015-03-13 |
| NuVasive X-CORE(R) Expandable VBR System (K142205) | Nuvasive, Inc. | 2015-02-20 |
| NUVASIVE NVM5 SYSTEM (K141968) | Nuvasive, Inc. | 2014-11-14 |
| COROENT TI-C SYSTEM (K140319) | Nuvasive, Inc. | 2014-10-09 |