Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Embody, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
163 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252647 | Tapestry Biointegrative Implant | Embody, Inc. | 2025-09-19 | 29 | 0 |
| K223822 | ACTIVBRAID™ | Embody, Inc. | 2023-06-02 | 163 | 0 |
| K220867 | Tapestry Biointegrative Implant | Embody, Inc. | 2022-05-23 | 59 | 0 |
| K213958 | Bioabsorbable Anchor | Embody, Inc. | 2022-04-08 | 112 | 0 |
| K212306 | Tapestry Biointegrative Implant | Embody, Inc. | 2021-11-02 | 102 | 0 |
| K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020-10-19 | 130 | 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