Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Aurora Spine, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

85 daysmedian FDA review time
181 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.2022-10-031780
K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc.2022-07-08560
K220610SOLO-LAurora Spine, Inc.2022-05-27850
K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.2021-08-021600
K210325APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc.2021-03-23470
K141317ZIP MIS INTERSPINOUS FUSION SYSTEMAurora Spine, Inc.2014-11-171810
K140715ZIP MIS INTERSPINOUS FUSION SYSTEMAurora Spine, Inc.2014-04-17270

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