Atlas FDA

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

Altus Partners, LLC — Predicate Candidate Screening

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

148 daysmedian FDA review time
309 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243419Altus Spine Navigation SystemAltus Partners, LLC2025-05-081850
K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC2022-09-165280
K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC2022-04-193090
K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC2021-08-201480
K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC2021-01-262950
K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC2020-06-021130
K183084Fuji Cervical Plate SystemAltus Partners, LLC2019-05-292040
K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC2019-02-221710
K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC2018-07-24640
K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC2018-06-11270
K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC2017-12-012800
K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC2017-11-211180
K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC2017-08-291160
K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC2017-03-10170
K163061Altus Spine Cervical Plate SystemAltus Partners, LLC2017-02-06970
K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC2017-01-252930
K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle ScAltus Partners, LLC2015-10-161200

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