Product code NQO
- Device name
- Prosthesis, Spinous Process Spacer/Plate
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P110008S015 | coflex® Interlaminar Technology | Companion Spine France | 2026-05-22 |
| P240043S001 | DIAM™ Spinal Stabilization System | Companion Spine France Sas | 2026-04-01 |
| P240043 | DIAM™ Spinal Stabilization System | Companion Spine France Sas | 2025-12-10 |
| P140004S034 | Superion Indirect Decompression System (IDS) System | Boston Scientific Neuromodulation | 2024-11-07 |
| P140004S033 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2024-08-22 |
| P140004S032 | Superion Indirect Decompression System (IDS) | Boston Scientific Neuromodulation | 2024-02-29 |
| P140004S030 | Superion Indirect Decompression System (IDS) | Boston Scientific Neuromodulation | 2023-05-11 |
| P140004S029 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2023-01-06 |
| P140004S028 | Vertiflex Instrument Platform (VIP) Kit | Boston Scientific Neuromodulation | 2022-03-02 |
| P140004S027 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2022-02-08 |
| P140004S026 | Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit | Boston Scientific Neuromodulation | 2021-10-07 |
| P140004S025 | Superion™ Indirect Decompression System (IDS) | Boston Scientific Neuromodulation | 2021-08-26 |
| P110008S013 | coflex Interlaminar Stabilization Device | Companion Spine France | 2021-03-31 |
| P140004S022 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2020-09-17 |
| P140004S020 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2020-09-16 |
| P140004S024 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2020-09-15 |
| P140004S023 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2020-09-09 |
| P140004S021 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2020-09-09 |
| P140004S019 | Superion Indirect Decompression System (IDS) | Boston Scientific Neuromodulation | 2020-08-14 |
| P140004S018 | Superion Indirect Decompression (IDS) System | Boston Scientific Neuromodulation | 2020-08-05 |
| P110008S012 | coflex® Interlaminar Technology | Companion Spine France | 2020-08-05 |
| P140004S017 | Superion Indirect Decompression System (IDS) | Boston Scientific Neuromodulation | 2020-07-22 |
| P110008S011 | coflex Interlaminar Stabilization Device | Companion Spine France | 2020-04-07 |
| P140004S016 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2019-12-02 |
| P140004S014 | Superion Indirect Decompression System | Boston Scientific Neuromodulation | 2019-09-10 |
| P140004S010 | Superion® Indirect Decompression System | Boston Scientific Neuromodulation | 2018-11-16 |
| P140004S015 | Superion® Indirect Decompression System | Boston Scientific Neuromodulation | 2018-08-24 |
| P110008S009 | Paradigm Spine Coflex Interlaminar Stabilization Device | Companion Spine France | 2018-06-21 |
| P110008S008 | coflex® Interlaminar Technology | Companion Spine France | 2018-04-25 |
| P110008S010 | COFLEX® INTERLAMINAR TECHNOLOGY | Companion Spine France | 2018-04-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03701521300354 | DIAM™ Spinal Stabilization System | COMPANION SPINE FRANCE | 2025-12-19 |
| 03701521300361 | DIAM™ Spinal Stabilization System | COMPANION SPINE FRANCE | 2025-12-19 |
| 03701521300378 | DIAM™ Spinal Stabilization System | COMPANION SPINE FRANCE | 2025-12-19 |
| 03701521300385 | DIAM™ Spinal Stabilization System | COMPANION SPINE FRANCE | 2025-12-19 |
| 03701521300347 | DIAM™ Spinal Stabilization System | COMPANION SPINE FRANCE | 2025-12-19 |
| 04260636678998 | coflex instrument loaner set | Paradigm Spine GmbH | 2023-03-31 |
| 00884662000529 | Superion™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | 2020-09-28 |
| 00088466000529 | Superion Indirect Decompression System | VERTIFLEX, INC. | 2019-02-04 |
| 04260148897825 | coflex crimping pliers, long | Paradigm Spine GmbH | 2018-10-23 |
| 04260148897849 | coflex dual pliers | Paradigm Spine GmbH | 2018-10-10 |
| 04260148897863 | coflex mallet cap | Paradigm Spine GmbH | 2018-08-02 |
| 04260148897856 | coflex Mallet | Paradigm Spine GmbH | 2018-08-02 |
| 04260148897771 | coflex trial with guide and x-ray marker, 14mm | Paradigm Spine GmbH | 2018-06-28 |
| 04260148897832 | coflex wing loosener | Paradigm Spine GmbH | 2018-06-28 |
| 04260148897801 | coflex trial cap | Paradigm Spine GmbH | 2018-06-28 |
| 04260148897795 | coflex trial slider with wings | Paradigm Spine GmbH | 2018-06-28 |
| 04260148897788 | coflex trial with guide and x-ray marker, 16mm | Paradigm Spine GmbH | 2018-06-28 |
| 04260148897764 | coflex trial with guide and x-ray marker, 12mm | Paradigm Spine GmbH | 2018-06-28 |
| 04260148897757 | coflex trial with guide and x-ray marker, 10mm | Paradigm Spine GmbH | 2018-06-28 |
| 04260148897740 | coflex trial with guide and x-ray marker, 8mm | Paradigm Spine GmbH | 2018-06-28 |
| 04260148898358 | coflex single-use instruments | Paradigm Spine GmbH | 2018-06-14 |
| 04260148890147 | coflex Mallet cap | Paradigm Spine GmbH | 2017-06-29 |
| 04260148890130 | coflex Mallet | Paradigm Spine GmbH | 2017-06-29 |
| 04260148890123 | coflex Crimping pliers | Paradigm Spine GmbH | 2017-06-29 |
| 04260148890116 | coflex Bending pliers | Paradigm Spine GmbH | 2017-06-29 |
| 04260148898341 | coflex Sterilization tray | Paradigm Spine GmbH | 2017-06-29 |
| 04260148898457 | coflex Interlaminar Technology, 8mm | Paradigm Spine GmbH | 2014-07-28 |
| 04260148898464 | coflex Interlaminar Technology, 10mm | Paradigm Spine GmbH | 2014-07-28 |
| 04260148898471 | coflex Interlaminar Technology, 12mm | Paradigm Spine GmbH | 2014-07-28 |
| 04260148898488 | coflex Interlaminar Technology, US, Size 14 | Paradigm Spine GmbH | 2014-07-28 |