Home › Device types › NQO
Prosthesis, Spinous Process Spacer/Plate
FDA product code NQO · Class 3 · Unknown
151
Registered devices
2,908
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
coflex crimping pliers, long — Paradigm Spine GmbHcoflex Trial, 10mm — Paradigm Spine GmbHX-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.Superion Retractor — VERTIFLEX, INC.X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.coflex Trial with wings and window, Size 14 — Paradigm Spine GmbHX-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.coflex Interlaminar Technology, US, Size 14 — Paradigm Spine GmbHX-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.Superion Dilator 1, Blunt — VERTIFLEX, INC.Superion™ — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONX-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.Superion Interspinous Reamer — VERTIFLEX, INC.Superion Dilator 1 — VERTIFLEX, INC.X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.coflex Interlaminar Technology, 12mm — Paradigm Spine GmbHcoflex Interlaminar Technology, 16mm — Paradigm Spine GmbHX-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.coflex Revision pliers — Paradigm Spine GmbHcoflex Crimping pliers — Paradigm Spine GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-06 | Boston Scientific Neuromodulation Corporation | As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance lev |
| 2023-05-12 | Boston Scientific Neuromodulation Corporation | Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrume |
| 2022-10-12 | Boston Scientific Neuromodulation Corporation | Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation |
| 2008-12-08 | Theragenics Corporation | Some pouches were found to have weak seals potentially compromising sterility. |
| 2008-01-30 | Kyphon Inc | Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/ |
| 2006-06-06 | St. Francis Medical Technologies Inc | Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant. |
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