Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interbody Innovations, Llp — 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) |
|---|---|---|---|---|---|
| K081614 | ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND | Interbody Innovations, Llp | 2008-09-05 | 88 | 0 |
| K073105 | PEEK SPINAL SPHERES | Interbody Innovations, Llp | 2008-01-03 | 62 | 0 |
| K062992 | SPINAL SPHERES | Interbody Innovations, Llp | 2007-07-27 | 298 | 0 |
| K051371 | INTERBODY INNOVATIONS CEMENT RESTRICTOR | Interbody Innovations, Llp | 2005-12-06 | 194 | 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