Home › Device types › MNI
Orthosis, Spinal Pedicle Fixation
FDA product code MNI · Class 2 · Orthopedic
180,144
Registered devices
3,997
Adverse events
213
Recalls
303
510(k) clearances
Devices with this code
CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLCArmada — Nuvasive, Inc.POLARIS 5.5 SPINAL SYSTEM — BIOMET SPINE LLCKora Spinal System — Medyssey Co., Ltd.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Iliad Spinal System — Medyssey Co., Ltd.Medyssey Spinal System - Rod — Medyssey Co., Ltd.AnyPlus Spinal Fixation System — GS Medical Co., Ltd.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Zenius Spinal System — Medyssey Co., Ltd.PressON™ — NEXUS SPINE, L.L.C.MONARCH — DEPUY SPINE, LLCMONARCH — DEPUY SPINE, LLCNA — Synthes GmbHNA — Synthes GmbHCD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Precept — Nuvasive, Inc.CorticaLINK — LINKSPINE, INC.REVERE — GLOBUS MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | XTANT Medical Holdings, Inc | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. |
| 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. |
| 2018-07-05 | CTL Medical Corporation | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle s |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
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