Atlas FDA

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

Astura Medical · Predicate Candidate Screening

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

148 daysmedian FDA review time
272 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular SpiAstura Medical2026-01-221340
K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular SpiAstura Medical2025-10-21850
K243259MASADA Modular Spinal Fixation SystemAstura Medical2025-01-07840
K240160EGPS Navigated InstrumentsAstura Medical2024-10-172720
K233359DOMINION Expandable Corpectomy SystemAstura Medical2024-03-081610
K231694MASADA Modular Spinal Fixation SystemAstura Medical2023-11-161600
K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical2023-10-24900
K223335SIRION Lateral Lumbar Interbody SystemAstura Medical2023-05-091890
K222097OLYMPIC Deformity Band SystemAstura Medical2023-05-042900
K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical2023-01-191490
K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical2022-03-30930
K182982BridalVeil Navigated InstrumentsAstura Medical2019-01-04670
K172166OLYMPIC Navigated InstrumentsAstura Medical2018-04-272830
K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical2018-04-182040
K173324ALTA Anterior Cervical Interbody SpacerAstura Medical2018-02-271300
K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical2017-10-021570
K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical2017-05-031420
K160702ZION Anterior Cervical Fixation SystemAstura Medical2016-08-231620
K160154ALTA Anterior Cervical Interbody SpacerAstura Medical2016-05-131140
K153446OLYMPIC Posterior Spinal Fixation SystemAstura Medical2016-04-081330
K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical2016-01-281480

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