Simplify® Cervical Artificial Disc
FDA premarket approval P200022/S013 · decided 2024-04-17
Approval details
- PMA number
- P200022
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Simplify® Cervical Artificial Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Nuvasive, Inc.
- Date received
- 2023-10-20
- Decision date
- 2024-04-17
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for updated labeling to reflect the findings of the 1-level extended follow-up of the IDE subjects.
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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 |