Prodisc C 09.820.055S

• FDA PMA P070001 decided 17 Dec 2007 Active
• FDA GUDID UDI-DI 00843193112842 listed 16 Oct 2018 Listed

• 2 recalls, same reason

  • Ongoing Z-2050-2026 FDA Class II ·initiated 20 Mar 2026
  • Ongoing Z-2051-2026 FDA Class II ·initiated 20 Mar 2026

  Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

• • Ongoing Z-1426-2026 FDA Class II ·initiated 31 Dec 2025

  Products were mislabeled as the 6mm product but included the 5 mm product.

• • Terminated Z-1406-2021 FDA Class II ·initiated 5 Mar 2021

  Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.

1. 17 Dec 2007 Approved FDA PMA P070001
2. 16 Oct 2018 Listed FDA GUDID 00843193112842
3. 5 Mar 2021 Recall initiated FDA recalls Z-1406-2021
4. 31 Dec 2025 Recall initiated FDA recalls Z-1426-2026
5. 20 Mar 2026 Recall initiated FDA recalls Z-2050-2026
6. 20 Mar 2026 Recall initiated FDA recalls Z-2051-2026

Trade name

Prodisc C

Generic name

Cervical total intervertebral disc prosthesis, modular

Model / reference

09.820.055S

Primary DI / UDI-DI

00843193112842

PMA number

P070001 ↗

FDA product code

MJO

GMDN term

Cervical total intervertebral disc prosthesis, modular

Device class

Class III

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Cervical total intervertebral disc prosthesis, modular

Other devices filed under FDA product code MJO (Prosthesis, Intervertebral Disc).

• 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.
• LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level) by Highridge Medical, LLC.
• Prestige LP Cervical Disc System by MEDTRONIC SOFAMOR DANEK, INC.

• Prodisc-C Nova XLD – H6mm

  Class III

  CE/MDR

• Prodisc-C Vivo Implant Xl - 7mm

  Class III

  CE/MDR

• Prodisc-C Nova M – H7mm

  Class III

  CE/MDR

• Prodisc-C Vivo Implant Medium - 5mm

  Class III

  CE/MDR

See all devices from Centinel Spine, LLC →