Novapproach Spine LLC
Novapproach Spine LLC appears in FDA public data with 2 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2213-2026, Class II) was initiated on Apr 23, 2026. Its most recent 510(k) clearance was granted on Jun 12, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2213-2026 | Class II | OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Sm | Apr 23, 2026 |
| Z-0246-2023 | Class II | OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of No | Oct 12, 2022 |