Novapproach Spine, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2213-2026Class IIOneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/SmApril 23, 2026
Z-0246-2023Class IIOneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NoOctober 12, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K251459OneLIF™ Interbody Fusion SystemJune 12, 2025
K211769OneLIF Intervertebral Body Replacement SystemSeptember 7, 2021