Woven Orthopedic Technologies: FDA clearances and approvals
Woven Orthopedic Technologies has 2 FDA 510(k) clearances (first 2023, latest 2023), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 89 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 2 | 89 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Woven Orthopedic Technologies's cleared 510(k)s took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QVI | Screw Sleeve Bone Fixation Device, Spine | 2 | 2 |
| QAC | Screw Sleeve Bone Fixation Device | 1 | 0 |
Review panels
- Orthopedic (3)
Most recent Woven Orthopedic Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233223 | OGmend® Implant Enhancement System | QVI | 2023-10-26 | 28 |
| K223075 | Ogmend® Implant Enhancement System | QVI | 2023-02-27 | 150 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180065 | De Novo | Screw Sleeve Bone Fixation Device | 2020-05-01 |
Recalls
openFDA lists no recalls under a recalling firm named Woven Orthopedic Technologies.
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 Woven Orthopedic Technologies have?
Woven Orthopedic Technologies has 2 FDA 510(k) clearances (first 2023, latest 2023), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Woven Orthopedic Technologies's 510(k)s?
The median time from FDA receipt to decision across Woven Orthopedic Technologies's cleared 510(k)s is 89 days.
What devices does Woven Orthopedic Technologies make?
Its most frequent FDA product codes are QVI (Screw Sleeve Bone Fixation Device, Spine, 2); QAC (Screw Sleeve Bone Fixation Device, 1).
Has Woven Orthopedic Technologies had device recalls?
openFDA lists no recalls under a recalling firm name matching Woven Orthopedic Technologies. Related entities may recall under other names.
Next steps
- See all 2 Woven Orthopedic Technologies clearances with predicates and recalls
- Run predicate analysis for product code QVI, Woven Orthopedic Technologies'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.