Atlas FDA

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

Medtronic Navigation — Predicate Candidate Screening

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

92 daysmedian FDA review time
142 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation2025-05-291150
K212397StealthStation S8 Cranial v2.0Medtronic Navigation2021-12-221421
K211442StealthStation Spinous Process ClampsMedtronic Navigation2021-07-08590
K201327NavLock TrackersMedtronic Navigation2020-06-18300
K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation2020-03-24920
K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation2018-11-02911
K180816Ziehm RFD 3D TrackerMedtronic Navigation2018-07-111040
K171267NavLock TrackersMedtronic Navigation2017-07-03631
K170011StealthStation S8 Spine Software v1.0.0Medtronic Navigation2017-05-011180

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