Atlas FDA

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

Science For Biomaterials — Predicate Candidate Screening

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

41 daysmedian FDA review time
125 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140226OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5Science For Biomaterials2014-06-031250
K120818OTIS-C PLUSScience For Biomaterials2012-04-19310
K090994LIGAFIX INTERFACE SCREWScience For Biomaterials2009-05-06290
K071155MODIFICATION TO: BIOSORB RESORBABLE VOID FILLERScience For Biomaterials2007-07-03690
K070507MODIFICATION TO: LIGAFIX INTERFERENCE SCREWScience For Biomaterials2007-03-29360
K061022BIO 1-KIT BIOSORB FILLED CARTRIDGEScience For Biomaterials2006-05-24410

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