Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Spine, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153695 | Biomet Spine Fusion System | Biomet Spine, LLC | 2016-01-21 | 29 | 0 |
| K151483 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015-07-31 | 59 | 0 |
| K142634 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015-03-12 | 176 | 0 |
| K141804 | POLARIS SPINAL SYSTEM - HA COATED | Biomet Spine, LLC | 2014-09-25 | 84 | 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