Embody, Inc.: FDA clearances and approvals
Embody, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time: 107 days. Since 2017 its median was 107 days, against 89 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 130 |
| 2021 | 1 | 102 |
| 2022 | 2 | 86 |
| 2023 | 1 | 163 |
| 2024 | 0 | — |
| 2025 | 1 | 29 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Embody, Inc.'s cleared 510(k)s took a median 107 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 |
|---|---|---|---|
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 4 | 4 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 | 1 |
Review panels
Most recent Embody, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252647 | Tapestry Biointegrative Implant | OWY | 2025-09-19 | 29 |
| K223822 | ACTIVBRAID | GAT | 2023-06-02 | 163 |
| K220867 | Tapestry Biointegrative Implant | OWY | 2022-05-23 | 59 |
| K213958 | Bioabsorbable Anchor | MAI | 2022-04-08 | 112 |
| K212306 | Tapestry Biointegrative Implant | OWY | 2021-11-02 | 102 |
| K201572 | TAPESTRY Biointegrative Implant | OWY | 2020-10-19 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Embody, 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 Embody, Inc. have?
Embody, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2025), across 3 product codes in 2 review panels.
How long does FDA take to clear Embody, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Embody, Inc.'s cleared 510(k)s is 107 days. Since 2017: 107 days, versus 89 days for all cleared 510(k)s in the same product codes.
What devices does Embody, Inc. make?
Its most frequent FDA product codes are OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, 4); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 1); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 1).
Has Embody, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Embody, Inc. Related entities may recall under other names.
Next steps
- See all 6 Embody, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWY, Embody, 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.