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NuVasive Specialized Orthopedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
20
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0500-2025Class IIPrecice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PSeptember 30, 2024
Z-0559-2023Class IINUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize November 1, 2022
Z-0319-2022Class IINUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item NumbeOctober 29, 2021
Z-1324-2021Class IIPrecice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fiFebruary 12, 2021
Z-1325-2021Class IIPRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pFebruary 12, 2021
Z-1351-2021Class IINUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged EFebruary 12, 2021
Z-1323-2021Class IIPRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, February 12, 2021
Z-1350-2021Class IINUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-HumerFebruary 12, 2021
Z-1349-2021Class IINUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE InFebruary 12, 2021
Z-0069-2021Class IINUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree BJuly 24, 2020
Z-0528-2022Class IIMAGEC 1 SystemJune 25, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K230765Precice Ankle Salvage SystemAugust 29, 2023
K220234Precice Intramedullary Limb Lengthening SystemMarch 15, 2023
K202348External Remote Controller ERC 4PDecember 22, 2020
K200430Precice® Ankle Salvage SystemSeptember 16, 2020
K201567Precice® Bone Transport SystemAugust 10, 2020
K201543MAGEC® SystemJuly 30, 2020
K193016PRECICE Bone Transport SystemMay 8, 2020
K193617Precice® ScrewsMay 8, 2020
K192181PRECICE Plating SystemNovember 7, 2019
K191336PRECICE SystemSeptember 26, 2019
K182170PRECICE® BONE TRANSPORT™ SystemFebruary 5, 2019
K180503PRECICE STRYDE SystemApril 3, 2018
K173129PRECICE SystemDecember 1, 2017
K172628PRECICE SystemSeptember 25, 2017
K172061PRECICE UNYTE SystemAugust 24, 2017
K170169PRECICE Intramedullary Limb Lengthening SystemJune 9, 2017
K162927PRECICE UNYTE CoCr SystemApril 6, 2017
K170346PRECICE Intramedullary Limb Lengthening SystemMarch 7, 2017
K160352MAGEC® Spinal Bracing and Distraction SystemOctober 21, 2016
K161751MAGEC® Spinal Bracing and Distraction SystemSeptember 2, 2016