Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Spine Technology, Inc. — 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) |
|---|---|---|---|---|---|
| K062686 | UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM | Advanced Spine Technology, Inc. | 2006-10-05 | 27 | 0 |
| K993066 | WINDOW CERVICAL DYNAMIC PLATE SYSTEM | Advanced Spine Technology, Inc. | 2000-06-07 | 349 | 0 |
| K992147 | TRIPLE-FIX SPINAL FIXATION SYSTEM | Advanced Spine Technology, Inc. | 2000-02-28 | 249 | 0 |
| K951266 | AMSET R-F SYSTEM | Advanced Spine Technology, Inc. | 1995-11-21 | 245 | 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