510(k) Report

FDA applicant

Innova Spinal Technologies, LLC

Boca Raton, FL2 decisions2014–20150 recalls

FDA records 2 decisions for Innova Spinal Technologies, LLC (Boca Raton, FL) from 2014 to 2015: 2 510(k) clearances. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 3 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 Innova Spinal Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Innova Spinal Technologies, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Innova”

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