FDA applicant

Intelivation, LLC

Saint Simons Island, GA3 decisions2021–20230 recalls

FDA records 3 decisions for Intelivation, LLC (Saint Simons Island, GA) from 2021 to 2023: 3 510(k) clearances. Most are in product codes HTY (Pin, Fixation, Smooth) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Intelivation”.

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

FDA decisions per year

1in 2023

2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

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Other applicant names beginning “Intelivation”

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

Intelivation Technologies 1

Intelivation, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Intelivation”