Atlas FDA

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

Medtronic Powered Surgical Solutions · Predicate Candidate Screening

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

99 daysmedian FDA review time
147 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth StoMedtronic Powered Surgical Solutions2021-11-23280
K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions2019-05-221470
K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions2019-05-121450
K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch hMedtronic Powered Surgical Solutions2017-05-151030
K163565MR8 Drill SystemMedtronic Powered Surgical Solutions2017-03-28990
K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Medtronic Powered Surgical Solutions2017-03-231290
K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions2016-05-26720
K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM7Medtronic Powered Surgical Solutions2009-03-26690
K072315MIDAS REX CURVED BURMedtronic Powered Surgical Solutions2007-09-18290

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