Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AlphatecLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list NuVasive Specialized Orthopedics with 25 510(k) clearances and 11 device recalls. The most recent is a 510(k) clearance dated Jun 18, 2026: Precice™ Max System and Precice™ Ankle Salvage System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 18, 2026 | Precice™ Max System and Precice™ Ankle Salvage SystemK261651 · HSB | 510(k) clearances |
| Sep 30, 2024 | Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade FemurClass II · Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected pr | Device recalls |
| Feb 6, 2024 | MAGEC Spinal Bracing and Distraction SystemK233593 · PGN | 510(k) clearances |
| Dec 15, 2023 | Precice Max SystemK232267 · HSB | 510(k) clearances |
| Aug 29, 2023 | Precice Ankle Salvage SystemK230765 · HSB | 510(k) clearances |
| Mar 15, 2023 | Precice Intramedullary Limb Lengthening SystemK220234 · HSB | 510(k) clearances |
| Nov 1, 2022 | NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF MClass II · During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of fa | Device recalls |
| Oct 29, 2021 | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-Class II · The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in p | Device recalls |
| Dec 22, 2020 | External Remote Controller ERC 4PK202348 · HSB | 510(k) clearances |
| Sep 16, 2020 | Precice® Ankle Salvage SystemK200430 · HSB | 510(k) clearances |
| Aug 10, 2020 | Precice® Bone Transport SystemK201567 · HSB | 510(k) clearances |
| Jun 25, 2019 | MAGEC 1 SystemClass II · Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
