Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Restore Surgical, LLC Dba Instratek · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017-02-10 | 175 | 0 |
| K161778 | ToeTac™ 10° Hammertoe Fixation System | Restore Surgical, LLC Dba Instratek | 2016-11-22 | 146 | 0 |
| K150443 | ToeTac Hammertoe Fixation System | Restore Surgical, LLC Dba Instratek | 2015-06-04 | 104 | 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