FDA applicant

Woven Orthopedic Technologies

Manchester, CT3 decisions2020–20230 recalls

FDA records 3 decisions for Woven Orthopedic Technologies (Manchester, CT) from 2020 to 2023: 2 510(k) clearances and 1 De Novo grant. Most are in product codes QVI (Screw Sleeve Bone Fixation Device, Spine) and QAC (Screw Sleeve Bone Fixation Device). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Woven Orthopedic Technologies, 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 Woven Orthopedic Technologies’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020high 2 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Woven Orthopedic Technologies by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Woven Orthopedic Technologies

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?