Atlas FDA

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

Lanx, Inc. — Predicate Candidate Screening

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

94 daysmedian FDA review time
178 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131547LANX FUSION SYSTEMLanx, Inc.2013-07-12441
K131156LANX SPINAL FIXATION SYSTEMLanx, Inc.2013-05-24300
K123767LANX FUSION SYSTEM- SALanx, Inc.2013-03-181014
K121316LANX SPINAL FIZATION SYSTEMLanx, Inc.2012-09-101310
K122145LANX SPINAL FIXATION SYSTEMLanx, Inc.2012-08-17291
K121940LANX SPINAL FIXATION SYSTEMLanx, Inc.2012-08-02310
K113434LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)Lanx, Inc.2011-12-19280
K112388LANX CERVICAL SALanx, Inc.2011-12-161200
K103091LANX SPINAL FIXATION SYSTEMLanx, Inc.2011-04-151780
K103237LANX SPINAL SYSTEMLanx, Inc.2011-03-251430
K103666LANX LATERALLanx, Inc.2011-03-23980
K103660LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMLanx, Inc.2011-02-28750
K100888MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATILanx, Inc.2010-11-152300
K101364LANX FACET SCREW SYSTEMLanx, Inc.2010-08-16940
K100935LANX SPINAL FIXATION SYSTEMLanx, Inc.2010-08-061230
K100191LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)Lanx, Inc.2010-04-15830
K092765LANX ANTERIOR PLATING SYSTEMLanx, Inc.2010-04-072100
K092656LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEMLanx, Inc.2009-11-24880
K092536SPINAL FIXATION SYSTEMLanx, Inc.2009-10-30720
K083815LANX FUSION SYSTEMLanx, Inc.2009-04-201190
K083581LANX SPINAL FIXATION SYSTEMLanx, Inc.2009-04-071240
K090316MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEMLanx, Inc.2009-04-07570
K090252MODIFICATION TO: LANX SPINAL FIXATION SYSTEMLanx, Inc.2009-03-04300

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