Simplify 1-4LEV-CE
Simplify 1-4LEV-CE is a Class III device made by NuVasive, LLC, approved under FDA PMA P200022 on 18 Sep 2020 and listed in FDA GUDID since 24 Apr 2023 (UDI-DI 00843285101884), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00843285101884 | Date24 Apr 2023 | StatusListed |
| United States | FDA PMA | NumberP200022 | Date18 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 00843285101884
- FDA PMA database P200022
Across registries
- FDA PMA P200022 decided 18 Sep 2020 Active
- FDA GUDID UDI-DI 00843285101884 listed 24 Apr 2023 Listed
Recalls
-
- Ongoing Z-1453-2022
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
Timeline
- Approved FDA PMA P200022
- Recall initiated FDA recalls Z-1453-2022
- Listed FDA GUDID 00843285101884
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Simplify
- Generic name
- Cervical total intervertebral disc prosthesis, modular
- Model / reference
- 1-4LEV-CE
- Primary DI / UDI-DI
- 00843285101884
- PMA number
- FDA product code
- MJO
- GMDN term
- Cervical total intervertebral disc prosthesis, modular
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
Similar devices
Other devices filed under FDA product code MJO (Prosthesis, intervertebral disc).
- ProDisc-C Total Disc Replacement by Centinel Spine, LLC
- PCM Cervical Disc System by Nuvasive, Inc.
- ACTIVL Artificial Disc by Highridge Medical, LLC.
- Prestige Cervical Disc by MEDTRONIC SOFAMOR DANEK, INC.
- Bryan Cervical Disc Prosthesis by Companion Spine France SAS
- BAGUERA®C Cervical Disc Prosthesis by Spineart USA, Inc.
- SECURE-C Cervical Artificial Disc by GLOBUS MEDICAL, INC.
- Charite Artificial Disc by Depuy Spine, Inc.
- M6-C Artificial Cervical Disc by Spinal Kinetics, LLC
- SECURE-C 414.308S by GLOBUS MEDICAL, INC.