Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Curiteva, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
211 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Por | Curiteva, Inc. | 2026-01-16 | 186 | 0 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026-01-15 | 29 | 0 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 | 90 | 0 |
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024-10-28 | 28 | 0 |
| K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | 2024-02-29 | 153 | 0 |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | 2024-01-18 | 57 | 0 |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023-06-28 | 61 | 0 |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023-02-13 | 510 | 0 |
| K223200 | Curiteva Navigation System | Curiteva, Inc. | 2023-01-06 | 85 | 0 |
| K210402 | Curiteva Sacroiliac Joint Fusion System | Curiteva, Inc. | 2021-09-09 | 211 | 0 |
| K191810 | Curiteva Pedicle Screw System | Curiteva, Inc. | 2019-08-28 | 54 | 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