FDA applicant

Nanovis Spine, LLC

Columbia City, IN3 decisions2015–20200 recalls

FDA records 3 decisions for Nanovis Spine, LLC (Columbia City, IN) from 2015 to 2020: 3 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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 Nanovis Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Nanovis Spine, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nanovis Spine, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Nanovis”

FDA records each applicant name separately; these may or may not be the same firm.

Nanovis, LLC 10

Nanovis Spine, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Nanovis”