Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sapphire Medical Group · 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) |
|---|---|---|---|---|---|
| K232619 | MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group | 2024-03-19 | 203 | 0 |
| K192316 | Matrix HA PEEK Cervical Implant System | Sapphire Medical Group | 2019-10-17 | 52 | 0 |
| K183073 | SMG Anterior Cervical Plate System | Sapphire Medical Group | 2019-02-11 | 98 | 0 |
| K172674 | Sapphire Cervical Implant System | Sapphire Medical Group | 2017-11-02 | 58 | 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