Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PHM · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018-05-31 | 97 | 0 |
| K160958 | Battalion Universal Spacer System | Alphatec Spine | 2016-09-08 | 156 | 0 |
| K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015-06-17 | 63 | 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