FDA applicant
4Web Medical, Inc.
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
How often FDA has decided 4Web Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
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.
See the 510(k) ReportOther applicant names beginning “4Web”
FDA records each applicant name separately; these may or may not be the same firm.