San Diego, CA, US · 4 510(k) clearances · 18 PMAs · 5 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2024-08-02 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | 1 | 2024-03-20 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2023-01-12 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | Class II | Orthopedic | 1 | 2021-08-20 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2025-06-05 | P200022-S016 | Simplify® Cervical Artificial Disc | 135 Review Track For 30-Day Notice | MJO | — | — |
| 2025-05-29 | P200022-S017 | Simplify® Cervical Artificial Disc | 30-Day Notice | MJO | — | — |
| 2025-02-18 | P200022-S012 | Simplify Disc | 135 Review Track For 30-Day Notice | MJO | — | — |
| 2025-02-13 | P200022-S015 | Simplify Cervical Artificial Disc | 30-Day Notice | MJO | — | — |
| 2024-12-18 | P200022-S014 | Simplify Cervical Artificial Disc | Normal 180 Day Track No User Fee | MJO | — | — |
| 2024-04-17 | P200022-S013 | Simplify® Cervical Artificial Disc | Normal 180 Day Track No User Fee | MJO | — | — |
| 2023-06-09 | P200022-S011 | Simplify Disc | 30-Day Notice | MJO | — | — |
| 2023-03-15 | P200022-S010 | Simplify Cervical Artificial Disc | Normal 180 Day Track | MJO | — | — |
| 2022-11-02 | P200022-S009 | Simplify Cervical Artificial Disc | Normal 180 Day Track No User Fee | MJO | — | — |
| 2022-02-09 | P200022-S008 | Simplify® Cervical Artificial Disc | 30-Day Notice | MJO | — | — |
| 2021-08-03 | P200022-S001 | Simplify Cervical Artificial Disc | Normal 180 Day Track No User Fee | MJO | — | — |
| 2021-07-21 | P200022-S007 | Simplify Cervical Artificial Disc | 30-Day Notice | MJO | — | — |
| 2021-05-28 | P200022-S005 | Simplify® Cervical Artificial Disc (2 Level) | Normal 180 Day Track No User Fee | MJO | — | — |
| 2021-05-26 | P200022-S006 | Simplify® Cervical Artificial Disc (One-Level) | Normal 180 Day Track No User Fee | MJO | — | — |
| 2021-04-01 | P200022-S003 | Simplify Cervical Artificial Disc | Panel Track | MJO | — | — |
| 2021-02-10 | P200022-S004 | Simplify Cervical Artificial Disc | 30-Day Notice | MJO | — | — |
| 2020-11-05 | P200022-S002 | Simplify Cervical Artificial Disc | Normal 180 Day Track No User Fee | MJO | — | — |
| 2020-09-18 | P200022 | Simplify® Cervical Artificial Disc | Original | MJO | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-11-10 | Class II | Ongoing | Z-0738-2023 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation. | — | Potential that insert will be unable to disengage from the vertebral body replacement device/implant |
| 2022-07-19 | Class III | Ongoing | Z-1052-2023 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US | — | Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper a… |
| 2022-06-20 | Class II | Ongoing | Z-1453-2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4;… | — | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may… |
| 2020-06-10 | Class II | Terminated | Z-2684-2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended fo… | — | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP ha… |
| 2020-02-13 | Class II | Terminated | Z-1898-2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use sp… | — | Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-08-02 | K233706 | Bendini Cloud Application | OLO | Class II | Neurology |
| 2024-03-20 | K240507 | NuVasive AttraX Scaffold | MQV | Class II | Orthopedic |
| 2023-01-12 | K223731 | NuVasive Modulus-C Interbody System | ODP | Class II | Orthopedic |
| 2021-08-20 | K211757 | Simplify Disc | QLQ | Class II | Orthopedic |