4Web Medical, Inc.: FDA clearances and approvals
4Web Medical, Inc. has 13 FDA 510(k) clearances (first 2021, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time: 126 days. Since 2017 its median was 126 days, against 96 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 92 |
| 2022 | 3 | 126 |
| 2023 | 3 | 103 |
| 2024 | 3 | 267 |
| 2025 | 2 | 45 |
| 2026 | 1 | 145 |
Review time against the same product codes
Since 2017, 4Web Medical, Inc.'s cleared 510(k)s took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 4 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| SAI | Ankle Fusion Cage | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent 4Web Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252834 | Sacroiliac Joint Truss System (SJTS) | OUR | 2026-01-28 | 145 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | OVE | 2025-12-11 | 76 |
| K251117 | Cervical Spine Truss System (CSTS) | OVE | 2025-04-25 | 14 |
| K240388 | Osteotomy Truss System (OTS) | HRS | 2024-11-01 | 267 |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | OVD | 2024-04-22 | 129 |
| K230088 | Ankle Truss System (ATS) | SAI | 2024-03-21 | 434 |
| K231739 | Cervical Spine Truss System (CSTS) | OVE | 2023-09-25 | 103 |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | OVE | 2023-02-02 | 91 |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | ODP | 2023-01-05 | 248 |
| K221283 | Hammertoe Truss System (HTS) | HTY | 2022-09-06 | 126 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 4Web Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does 4Web Medical, Inc. have?
4Web Medical, Inc. has 13 FDA 510(k) clearances (first 2021, latest 2026), across 9 product codes in 1 review panel.
How long does FDA take to clear 4Web Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across 4Web Medical, Inc.'s cleared 510(k)s is 126 days. Since 2017: 126 days, versus 96 days for all cleared 510(k)s in the same product codes.
What devices does 4Web Medical, Inc. make?
Its most frequent FDA product codes are OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 4); HRS (Plate, Fixation, Bone, 2); HTY (Pin, Fixation, Smooth, 1).
Has 4Web Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching 4Web Medical, Inc. Related entities may recall under other names.
Next steps
- See all 13 4Web Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OVE, 4Web Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.