Atlas FDA

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

Astura Medical, LLC · Predicate Candidate Screening

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

200 daysmedian FDA review time
248 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC2021-01-061280
K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC2020-10-26910
K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC2020-04-212230
K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC2020-04-022480
K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC2019-10-242440
K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC2019-05-032000
K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC2018-10-18590
K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC2018-07-06670

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