510(k) Report

FDA applicant

4Web Medical, Inc.

Frisco, TX13 decisions2021–20260 recalls

FDA records 13 decisions for 4Web Medical, Inc. (Frisco, TX) from 2021 to 2026: 13 510(k) clearances. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “4Web Medical”.

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 4Web Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2021: 12022: 32023: 32024: 32025: 22026 (partial year): 1
2021high 3 (2022) · low 1 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — 4Web Medical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 4Web Medical, Inc.’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 “4Web”

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