FDA applicant

Additive Device, Inc. (Adi) D/B/A Restor3D

Durham, NC2 decisions2019–20190 recalls

FDA records 2 decisions for Additive Device, Inc. (Adi) D/B/A Restor3D (Durham, NC) in 2019: 2 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and PLF (Bone Wedge). Its devices cite 2 predicates, 0 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 Additive Device, Inc. (Adi) D/B/A Restor3D’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Additive Device, Inc. (Adi) D/B/A Restor3D by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Additive Device, Inc. (Adi) D/B/A…’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 “Additive”

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

Additive Orthopaedics, LLC 7 Additive Implants, Inc. 3

Additive Device, Inc. (Adi) D/B/A Restor3D

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 “Additive”