Atlas FDA

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

K2m — Predicate Candidate Screening

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

97 daysmedian FDA review time
140 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182182YUKON OCT Spinal SystemK2m2018-11-15940
K181890Brainlab Compatible K2M Navigation InstrumentsK2m2018-11-091190
K172941CASCADIA Interbody SystemK2m2018-02-121390
K171556K2M Navigation InstrumentsK2m2018-01-162310
K173508Everest Spinal SystemK2m2018-01-09570
K171704CAPRI Corpectomy Cage SystemK2m2017-08-31840
K171321K2M Navigation InstrumentsK2m2017-08-301180
K170055CAPRI Corpectomy Cage SystemK2m2017-04-13970
K163364MOJAVE Expandable Interbody SystemK2m2017-03-151050
K153526Pyrenees Cervical Plate SystemK2m2016-04-271400
K160125Cascadia Interbody SystemK2m2016-04-22930
K160547Cascadia Interbody SystemK2m2016-03-24270
K152872K2M Fenestrated Tap SystemK2m2016-01-05970
K152281Pyrenees Cervical Plate SystemK2m2015-09-24430
K150983Pyrenees Cervical Plate SystemK2m2015-07-14910
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m2014-12-221020

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