Atlas FDA

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

K2m, LLC — Predicate Candidate Screening

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

105 daysmedian FDA review time
264 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystK2m, LLC2018-11-282590
K140529EVEREST SPINAL SYSTEMK2m, LLC2014-05-22790
K052404DENALI DEFORMITY SYSTEMK2m, LLC2006-05-232640
K060442PYRENEES CERVICAL PLATE SYSTEMK2m, LLC2006-05-15830
K052398MESA SPINAL SYSTEMK2m, LLC2005-12-07980
K051531TECTONIC CERVICAL PLATE SYSTEMK2m, LLC2005-10-171300
K051454ALEUTIAN SPACER SYSTEMK2m, LLC2005-07-27550
K042635DENALI SPINE SYSTEMK2m, LLC2005-01-101050

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