510(k) Report

FDA applicant

Novapproach Spine

Alachua, FL2 decisions2021–20252 recalls

FDA records 2 decisions for Novapproach Spine (Alachua, FL) from 2021 to 2025: 2 510(k) clearances. All are in product code OVD (Intervertebral Fusion Device With Integrated…). Its devices cite 5 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Novapproach Spine, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Novapproach Spine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12025: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2026

2022: 12026 (partial year): 1
2021high 1 (2022) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Novapproach Spine by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine · 20211cites it

What has FDA decided for it lately?

  • K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC · 2025
  • K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine · 20212 recalls

The one decision as Novapproach Spine →The one decision as Novapproach Spine, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K211769OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm…Apr 23, 2026Class II
  • K211769OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a…Oct 12, 2022Class II