510(k) K211769 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
OneLIF Intervertebral Body Replacement System
| Applicant | Novapproach Spine, Alachua FL, US |
| Decision | Substantially Equivalent, Sep 7, 2021 |
| Received | Jun 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211769
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2026 | Novapproach Spine, LLC OneLIF Interbody Cage (REF/Description):
010-107-1007/Small 7 Degree 10mm X 7mm,
010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique,
010-107-1209/Small 7 Degree 12mm X 9mm,
010-107-1411/Small 7 Degree Open, Classified |
OVD | None listed |
| Nov 17, 2022 | Novapproach Spine LLC OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS. Terminated |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.