Simplify Cervical Artificial Disc
FDA premarket approval P200022/S003 · decided 2021-04-01
Approval details
- PMA number
- P200022
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Simplify Cervical Artificial Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Nuvasive, Inc.
- Date received
- 2020-10-27
- Decision date
- 2021-04-01
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for Simplify® Cervical Artificial Disc that is indicated for use in skeletally mature patients for reconstruction of the disc at one or two contiguous levels from C3-C7 following discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |