Atlas FDA

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

Life Spine — Predicate Candidate Screening

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

90 daysmedian FDA review time
262 days90th percentile
36clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182470Plateau Spacer SystemLife Spine2018-11-26770
K160169The Life Spine Subtalar Implant SystemLife Spine2016-06-231480
K150368Tarsa-Link Wedge Fixation SystemLife Spine2015-03-24400
K141905PRO-LINK WEDGE SYSTEMLife Spine2014-09-26730
K133717LONGBOW SPACER SYSTEMLife Spine2014-09-192880
K131077LIFE SPINE PLATEAU SPACER SYSTEMLife Spine2013-07-17910
K123373NAUTILUS SPINAL SYSTEMLife Spine2013-03-061250
K120998SOLSTICE CROSS CONNECTORLife Spine2012-10-011820
K111953NAUTILUS SPINAL SYSTEMLife Spine2012-08-073930
K121116PLATEAU SPACER SYSTEMLife Spine2012-05-08260
K113157AILERON INTERSPINOUS FIXATION SYSTEMLife Spine2012-03-131390
K111569PLATEAU SPACER SYSTEMLife Spine2011-07-06300
K103423MIS ANTERIOR CERVICAL PLATING SYSTEMLife Spine2011-06-011910
K100407LIFE SPINE INTERSPINOUS FIXATION SYSTEMLife Spine2010-11-052620
K093093SMALL PLATEAU SPACER SYSTEMLife Spine2010-10-133770
K093200LIFE SPINE LUMBAR PLATE SYSTEMLife Spine2010-01-191020
K091301LIFE SPINE STAND-ALONE SPACER SYSTEMLife Spine2009-12-152250
K090343SENTINEL SPINAL SYSTEMLife Spine2009-08-111820
K090320CONQUEST SPINAL SYSTEMLife Spine2009-07-221630
K090865LIFE SPINE FACET SCREW SPINAL SYSTEMLife Spine2009-06-26880
K083865PILOT SPINAL SYSTEMLife Spine2009-01-28300
K080767CONQUEST SPINAL SYSTEMLife Spine2008-05-21640
K080411PLATEAU SPACER SYSTEMLife Spine2008-05-15900
K080502MODIFICATION TO:PILOT SPINAL SYSTEMLife Spine2008-04-08430
K073274SPINAL SPHERE SYSTEMLife Spine2008-03-171170
K073479KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEMLife Spine2008-01-09290
K073480LIFE SPINE CROSS CONNECTORLife Spine2008-01-04240
K070995ARX-LINK CROSS CONNECTORLife Spine2007-06-22740
K070285LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEMLife Spine2007-03-13430
K063601PILOT SPINAL SYSTEMLife Spine2007-01-25520
K062643KINETIC ANTERIOR CERVICAL PLATELife Spine2006-11-16710
K062831MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTELife Spine2006-10-19290
K061364PILOT POSTERIOR LUMBAR PLATING SYSTEMLife Spine2006-09-051120
K061600ARX SPINAL SYSTEMLife Spine2006-08-22750
K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife Spine2006-07-12260
K060247LIFE SPINE CEMENT RESTRICTORLife Spine2006-05-111000

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