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

Medtronic Surgical Navigation Technologies — Predicate Candidate Screening

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

61 daysmedian FDA review time
186 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K050438STEALTHSTATION SYSTEM UPDATEMedtronic Surgical Navigation Technologies2005-06-021009
K043088MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULEMedtronic Surgical Navigation Technologies2005-01-05581
K030552IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies2003-03-19261
K030106STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWAREMedtronic Surgical Navigation Technologies2003-02-12300
K022126CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies2003-01-031860
K021980HIP MODULE FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies2002-11-191552
K022414STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACEMedtronic Surgical Navigation Technologies2002-08-14210
K020338STEALTHSTATION WITH FLUOROMERGE SOFTWAREMedtronic Surgical Navigation Technologies2002-02-27260
K012937KNEE MODULE FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies2002-01-2514726
K002869LOCALISA CARDIAC NAVIGATION SYSTEMMedtronic Surgical Navigation Technologies2001-03-271950
K003201STEALTHSTATION TREATMENT GUIDANCE PLATFORMMedtronic Surgical Navigation Technologies2000-12-12610
K001284STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTMedtronic Surgical Navigation Technologies2000-06-125226

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