Evolution Spine

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260038E3D™-C Interbody SystemFebruary 4, 2026
K250167Evolution Spine Navigation InstrumentsAugust 18, 2025
K241846E3D™-C Interbody SystemAugust 12, 2024
K240368E3D™-A Interbody SystemMay 15, 2024
K232432E3D™-A Interbody SystemJanuary 30, 2024
K223146EVOLUTION SPINE Interbody SystemFebruary 7, 2023
K220275EMERGE Anterior Cervical Plate SystemMarch 18, 2022
K212405EMERGE™ Anterior Cervical Plate SystemSeptember 30, 2021
K182478Whistler Modular Pedicle Screw SystemJanuary 15, 2019
K180755Vail ALIF Buttress Plate SystemJuly 6, 2018
K173375Anterior Cervical Plate SystemDecember 21, 2017
K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)November 16, 2016
K160324Cervical Interbody Fusion SystemMay 5, 2016