Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clariance — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
371 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 | 26 | 1 |
| K243670 | Idys® LIF | Clariance | 2024-12-31 | 34 | 0 |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024-07-24 | 27 | 0 |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation | Clariance | 2024-04-26 | 28 | 0 |
| K240715 | Idys® C ZP 3DTi | Clariance | 2024-03-22 | 7 | 0 |
| K220182 | Aggeris™-C | Clariance | 2022-03-30 | 68 | 0 |
| K200919 | Idys ALIF 3DTi | Clariance | 2021-04-12 | 371 | 0 |
| K130853 | IDYS(TM) C | Clariance | 2013-11-13 | 230 | 0 |
| K131178 | IDYS LIF CAGES | Clariance | 2013-10-10 | 168 | 0 |
| K120469 | ERISMA-LP | Clariance | 2012-08-13 | 179 | 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