Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alphatec Spine — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
264 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ AL | Alphatec Spine | 2025-09-03 | 104 | 0 |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interb | Alphatec Spine | 2025-02-03 | 264 | 0 |
| K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024-06-06 | 59 | 0 |
| K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Int | Alphatec Spine | 2022-10-07 | 88 | 0 |
| K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine | 2019-06-03 | 31 | 0 |
| K160958 | Battalion Universal Spacer System | Alphatec Spine | 2016-09-08 | 156 | 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