Home › Device types › KWP
Appliance, Fixation, Spinal Interlaminal
FDA product code KWP · Class 2 · Orthopedic
199,689
Registered devices
14,567
Adverse events
68
Recalls
430
510(k) clearances
Devices with this code
EXPEDIUM — Medos International SàrlLineSider — Integrity Implants Inc.Reform Pedicle Screw System — PRECISION SPINE, INC.Reform TI Pedicle Screw System — PRECISION SPINE, INC.EVEREST Spinal System — VB Spine LLCVirata — Seaspine Orthopedics CorporationAccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.AccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.AccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.AccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.AccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.AccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.CD Horizon™ ModuLeX™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Palladian™ — NEUROSTRUCTURES, INCSochi — Altus Spine, LLCREVERE — GLOBUS MEDICAL, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Vitality® — BIOMET SPINE LLCVITALITY® — BIOMET SPINE LLCAPEX-DL Spine System — SPINECRAFT, LLCAPEX Spine System — SPINECRAFT, LLCReLine — Nuvasive, Inc.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2022-06-13 | K2M, Inc. | Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may |
| 2022-01-13 | K2M, Inc | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dil |
| 2022-01-13 | K2M, Inc | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dil |
| 2020-03-26 | Medtronic Sofamor Danek USA Inc | Nonconforming product; length of the product measured shorter than the labeled length. |
| 2020-01-28 | Medicrea International | An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw inserti |
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