Valencia, CA, US · 7 510(k) clearances · 17 PMAs · 7 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Class II | Neurology | 5 | 2024-08-23 |
| GXD | Generator, Lesion, Radiofrequency | Class II | Neurology | 1 | 2025-08-07 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Class II | Neurology | 1 | 2024-08-21 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2024-11-07 | P140004-S034 | Superion Indirect Decompression System (IDS) System | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2024-08-22 | P140004-S033 | Superion Indirect Decompression System | Normal 180 Day Track | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2024-02-29 | P140004-S032 | Superion Indirect Decompression System (IDS) | Real-Time Process | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2023-05-11 | P140004-S030 | Superion Indirect Decompression System (IDS) | Real-Time Process | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2023-01-06 | P140004-S029 | Superion Indirect Decompression System | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2022-03-02 | P140004-S028 | Vertiflex Instrument Platform (VIP) Kit | Real-Time Process | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2022-02-08 | P140004-S027 | Superion Indirect Decompression System | Normal 180 Day Track No User Fee | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2021-10-07 | P140004-S026 | Superion Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2021-08-26 | P140004-S025 | Superion Indirect Decompression System (IDS) | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-09-17 | P140004-S022 | Superion Indirect Decompression System | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-09-16 | P140004-S020 | Superion Indirect Decompression System | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-09-15 | P140004-S024 | Superion Indirect Decompression System | Normal 180 Day Track No User Fee | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-09-09 | P140004-S023 | Superion Indirect Decompression System | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-09-09 | P140004-S021 | Superion Indirect Decompression System | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-08-14 | P140004-S019 | Superion Indirect Decompression System (IDS) | 30-Day Notice | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-08-05 | P140004-S018 | Superion Indirect Decompression (IDS) System | Real-Time Process | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| 2020-07-22 | P140004-S017 | Superion Indirect Decompression System (IDS) | Normal 180 Day Track No User Fee | NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-08 | Class II | Ongoing | Z-2558-2025 | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 | — | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks pre… |
| 2025-07-08 | Class II | Ongoing | Z-2340-2025 | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu… | — | Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brai… |
| 2025-06-06 | Class II | Ongoing | Z-2485-2025 | Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect … | — | As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance lev… |
| 2024-07-17 | Class II | Ongoing | Z-2617-2024 | WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 | — | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may… |
| 2024-04-18 | Class II | Ongoing | Z-1890-2024 | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG K… | — | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device… |
| 2023-05-12 | Class II | Ongoing | Z-1972-2023 | Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect De… | — | 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 | Class II | Ongoing | Z-0230-2023 | Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14m… | — | 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 … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-08-07 | K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | GXD | Class II | Neurology |
| 2024-08-23 | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | GZB | Class II | Neurology |
| 2024-08-21 | K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | GZF | Class II | Neurology |
| 2022-06-10 | K221376 | Nalu Neurostimulation System | GZB | Class II | Neurology |
| 2021-03-25 | K203547 | Nalu Neurostimulation System | GZB | Class II | Neurology |
| 2020-11-09 | K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits | GZB | Class II | Neurology |
| 2020-07-15 | K201618 | Nalu Neurostimulation SCS system | GZB | Class II | Neurology |