Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Cohort Medical Products Group, Inc. · Predicate Candidate Screening

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

93 daysmedian FDA review time
307 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964975COHORT DISCECTOMY SYSTEMS (CDS)Cohort Medical Products Group, Inc.1997-02-24740
K950011COHORT(TM) ANTERIOR PLATE SYSTEM (APS)Cohort Medical Products Group, Inc.1995-11-063070
K943804BONE SCREWCohort Medical Products Group, Inc.1994-12-081260
K943472COHORT AVB RETRACTOR SYSTEMCohort Medical Products Group, Inc.1994-10-20930
K943474CANNULATED BONE SCREWCohort Medical Products Group, Inc.1994-10-14870

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