Atlas FDA

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

Auxein Medical Private Limited · Predicate Candidate Screening

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

378 daysmedian FDA review time
492 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited2023-11-305270
K213059Tibia and Fibula SystemAuxein Medical Private Limited2023-01-274920
K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOAuxein Medical Private Limited2022-12-164480
K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited2022-11-184240
K213108Humerus & Ulna SystemAuxein Medical Private Limited2022-11-044060
K213014Varixis Elbow SystemAuxein Medical Private Limited2022-10-033780
K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited2022-08-223320
K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited2022-07-293080
K2113242.4mm Distal Radius SystemAuxein Medical Private Limited2022-03-143180
K210792Auxein Nailing SystemAuxein Medical Private Limited2021-08-251630
K203029Auxilock Titanium Interference ScrewAuxein Medical Private Limited2021-08-203220
K192003Auxein Nailing SystemAuxein Medical Private Limited2020-06-103200

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