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Prodisc C 09.820.046S

by Centinel Spine, LLC

Prodisc C 09.820.046S is a Class III device made by Centinel Spine, LLC, approved under FDA PMA P070001 on 17 Dec 2007 and listed in FDA GUDID since 16 Oct 2018 (UDI-DI 00843193112828), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P070001

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843193112828 UDI-DI Date16 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP070001 Date17 Dec 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P070001 decided 17 Dec 2007 Active
  • FDA GUDID UDI-DI 00843193112828 listed 16 Oct 2018 Listed

Recalls

4 recalls · 3 ongoing · FDA

  • 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.

Timeline

6 dated events

  1. Approved FDA PMA P070001
  2. Listed FDA GUDID 00843193112828
  3. Recall initiated FDA recalls Z-1406-2021
  4. Recall initiated FDA recalls Z-1426-2026
  5. Recall initiated FDA recalls Z-2050-2026
  6. Recall initiated FDA recalls Z-2051-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Prodisc C
Generic name
Cervical total intervertebral disc prosthesis, modular
Model / reference
09.820.046S
Primary DI / UDI-DI
00843193112828
PMA number
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

Related devices

Category: Cervical total intervertebral disc prosthesis, modular

Cleared under the same submission (P070001)

and 8 more cleared under P070001

Similar devices

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

Other devices from Centinel Spine, LLC

See all devices from Centinel Spine, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)