Home › Device types › MNI
Orthosis, Spinal Pedicle Fixation
FDA product code MNI · Class 2 · Orthopedic
179,820
Registered devices
3,989
Adverse events
213
Recalls
303
510(k) clearances
Devices with this code
REVERE — GLOBUS MEDICAL, INC.REVERE — GLOBUS MEDICAL, INC.REVOLVE — GLOBUS MEDICAL, INC.POLARIS 4.75 SPINAL SYSTEM — BIOMET SPINE LLCMulti-Axial Screw — Shandong Weigao Orthopaedic Device Co., Ltd.POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLCPolaris™ 4.75 Spinal System — BIOMET SPINE LLCPolaris™ 4.75 Spinal System — BIOMET SPINE LLCPOLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLCEasyspine — LDR Spine Usa, Inc.Vitality® — BIOMET SPINE LLCST360°® — ZIMMER SPINE, INC.M.U.S.T. Rods — Medacta International SAEasyspine — LDR Spine Usa, Inc.Easyspine — LDR Spine Usa, Inc.UNI-THREAD® — SPINEVISIONErisma®-LP — CLARIANCEErisma®-LP — CLARIANCEANAXTM5.5 Spinal System — CG MedTech Co.,Ltd.uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KGflamenco™ spinal fixation system — Ulrich GmbH & Co. KGES2 SPINAL SYSTEM — Stryker CorporationMatrix — Synthes GmbHNA — SYNTHES (U.S.A.) LP
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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