Evolution Spine

FDA Regulatory Profile

Evolution Spine appears in FDA public data with 0 recalls, 14 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jul 22, 2026.

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K262094E3D™-C Interbody SystemJul 22, 2026
K260038E3D™-C Interbody SystemFeb 4, 2026
K250167Evolution Spine Navigation InstrumentsAug 18, 2025
K241846E3D™-C Interbody SystemAug 12, 2024
K240368E3D™-A Interbody SystemMay 15, 2024
K232432E3D™-A Interbody SystemJan 30, 2024
K223146EVOLUTION SPINE Interbody SystemFeb 7, 2023
K220275EMERGE Anterior Cervical Plate SystemMar 18, 2022
K212405EMERGE™ Anterior Cervical Plate SystemSep 30, 2021
K182478Whistler Modular Pedicle Screw SystemJan 15, 2019
K180755Vail ALIF Buttress Plate SystemJul 6, 2018
K173375Anterior Cervical Plate SystemDec 21, 2017
K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Nov 16, 2016
K160324Cervical Interbody Fusion SystemMay 5, 2016