4Web, Inc.: FDA clearances and approvals
4Web, Inc. has 13 FDA 510(k) clearances (first 2014, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time: 138 days. Since 2017 its median was 134 days, against 97 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 50 |
| 2015 | 1 | 147 |
| 2016 | 1 | 192 |
| 2017 | 3 | 122 |
| 2018 | 2 | 154 |
| 2019 | 2 | 118 |
| 2020 | 1 | 148 |
| 2021 | 1 | 152 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 139 |
Review time against the same product codes
Since 2017, 4Web, Inc.'s cleared 510(k)s took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 6 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent 4Web, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | KWQ | 2026-02-12 | 139 |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | KWQ | 2021-03-10 | 152 |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device | OVD | 2020-05-29 | 148 |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | OVE | 2019-08-12 | 131 |
| K190926 | Hammertoe Truss System (HTS) | HTY | 2019-07-23 | 105 |
| K172294 | Osteotomy Truss System (OTS) | HRS | 2018-02-22 | 206 |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | ODP | 2018-01-08 | 101 |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | MAX | 2017-11-07 | 91 |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | MAX | 2017-09-08 | 122 |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | MAX | 2017-08-07 | 138 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 4Web, 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, Inc. have?
4Web, Inc. has 13 FDA 510(k) clearances (first 2014, latest 2026), across 7 product codes in 1 review panel.
How long does FDA take to clear 4Web, Inc.'s 510(k)s?
The median time from FDA receipt to decision across 4Web, Inc.'s cleared 510(k)s is 138 days. Since 2017: 134 days, versus 97 days for all cleared 510(k)s in the same product codes.
What devices does 4Web, Inc. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 6); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); HRS (Plate, Fixation, Bone, 1).
Has 4Web, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching 4Web, Inc. Related entities may recall under other names.
Next steps
- See all 13 4Web, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, 4Web, 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.