Atlas FDA

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

Lanx, LLC — Predicate Candidate Screening

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

62 daysmedian FDA review time
150 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120399LANX SPINAL FIXATION SYSTEMLanx, LLC2012-03-09300
K102738LANX FUSION SYSTEMLanx, LLC2011-02-101411
K103040LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)Lanx, LLC2011-02-081180
K093285MODIFICATION TO LANX SPINAL FIXATION SYSTEMLanx, LLC2009-12-10510
K082774LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICELanx, LLC2008-10-21290
K073144LANX INTERVERTEBRAL BODY FUSION DEVICELanx, LLC2008-01-24780
K071905POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)Lanx, LLC2007-12-281710
K071877LANX SPINAL FIXATION SYSTEMLanx, LLC2007-09-17700
K071633LANX DEFORMITY SYSTEMLanx, LLC2007-08-15620
K052384LANX VBR SYSTEMLanx, LLC2005-10-07380
K043484LANX SPINAL FIXATION SYSTEMLanx, LLC2005-05-161500
K050774LANX ANTERIOR CERVICAL PLATE SYSTEMLanx, LLC2005-04-11170
K040401LANX ANTERIOR CERVIAL PLATE SYSTEMLanx, LLC2004-04-12550

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