Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
4Web Medical, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
279 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025-12-11 | 76 | 0 |
| K240388 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | 2024-11-01 | 267 | 0 |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024-04-22 | 129 | 0 |
| K230088 | Ankle Truss System (ATS) | 4Web Medical, Inc. | 2024-03-21 | 434 | 0 |
| K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023-09-25 | 103 | 0 |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbod | 4Web Medical, Inc. | 2023-02-02 | 91 | 0 |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | 4Web Medical, Inc. | 2023-01-05 | 248 | 0 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 | 126 | 0 |
| K220463 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | 2022-05-18 | 90 | 0 |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 4Web Medical, Inc. | 2022-05-17 | 279 | 0 |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | 4Web Medical, Inc. | 2021-08-05 | 92 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda