Atlas FDA

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

Osteomedics, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time
210 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022035OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORBOsteomedics, Inc.2003-01-172100
K022324NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEMOsteomedics, Inc.2002-09-17621
K022231NORMED DISTAL RADIUS RECONSTRUCTION SYSTEMOsteomedics, Inc.2002-09-13650
K022230NORMED MINI EXTERNAL FIXATOR SYSTEMOsteomedics, Inc.2002-09-10620
K022323NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEMOsteomedics, Inc.2002-09-09540
K022325NORMED TITANIUM OSTEOTOMY PLATING SYSTEMOsteomedics, Inc.2002-09-09541
K021341NORMED BONE TRANSPORT DISTRACTION DEVICEOsteomedics, Inc.2002-08-01940
K021342NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOROsteomedics, Inc.2002-08-01940
K010118NORMED MANDIBULAR FIXATION SYSTEMOsteomedics, Inc.2001-08-142100

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