Home › Device types › MJO
Prosthesis, Intervertebral Disc
FDA product code MJO · Class 3 · Unknown
607
Registered devices
6,148
Adverse events
15
Recalls
0
510(k) clearances
Devices with this code
SECURE-C — GLOBUS MEDICAL, INC.Prestige LP Streamlined Instruments — MEDTRONIC SOFAMOR DANEK, INC.Mobi-C® Plug & Fit US — LDR Spine Usa, Inc.BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.ActivL — Highridge Medical, LLCPrestige LP Streamlined Instruments — MEDTRONIC SOFAMOR DANEK, INC.SECURE-C — GLOBUS MEDICAL, INC.Mobi-C — LDR Spine Usa, Inc.activL® — Aesculap AGPCM — Nuvasive, Inc.Prodisc C Nova — Centinel Spine, Inc.Mobi-C Plug & Fit US — ZIMMER BIOMET INCSimplify — Nuvasive, Inc.PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.Simplify® Cervical Artificial Disc — Nuvasive, Inc.Simplify — Nuvasive, Inc.ProDisc — SYNTHES (U.S.A.) LPPRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.Mobi-C® Plug & Fit US — LDR Spine Usa, Inc.Simplify® Cervical Artificial Disc — Nuvasive, Inc.ProDisc — SYNTHES (U.S.A.) LPM6-C — Spinal Kinetics, Inc.ProDisc — SYNTHES (U.S.A.) LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-20 | Centinel Spine, Inc. | 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 la |
| 2026-03-20 | Centinel Spine, Inc. | 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 la |
| 2025-12-31 | Centinel Spine, Inc. | Products were mislabeled as the 6mm product but included the 5 mm product. |
| 2024-07-18 | Centinel Spine, Inc. | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not hav |
| 2024-07-18 | Centinel Spine, Inc. | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not hav |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2022-06-20 | NuVasive Inc | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may |
| 2021-03-05 | Centinel Spine, Inc. | 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 Sur |
| 2018-03-13 | Medtronic Sofamor Danek USA Inc | The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interac |
| 2007-09-04 | Medtronic Sofamor Danek USA Inc | Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated. |
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