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

Synthes Spine Co.Lp · Predicate Candidate Screening

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

110 daysmedian FDA review time
272 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)Synthes Spine Co.Lp2012-07-25300
K112459SYNTHES ZERO-PSynthes Spine Co.Lp2011-12-121080
K112068SYNTHES ZERO-P VARIABLE ANGLE (VA)Synthes Spine Co.Lp2011-11-071101
K103320SYNTHES XRLSynthes Spine Co.Lp2011-10-203421
K081568ANTEGRA-TSynthes Spine Co.Lp2008-09-02900
K080020ARCOFIXSynthes Spine Co.Lp2008-05-231410
K072981SYNTHES ZERO-PSynthes Spine Co.Lp2008-02-111112
K072434SYNTHES OC FUSION AND SYNAPSE SYSTEMSSynthes Spine Co.Lp2008-01-101340
K072253SYNFIX-LR SPACERSynthes Spine Co.Lp2007-10-12591
K070573SYNAPSE SYSTEMSynthes Spine Co.Lp2007-06-081000
K062083SYNFIX -LRSynthes Spine Co.Lp2007-04-032560
K062933SYNTHES ORACLE SPACERSynthes Spine Co.Lp2007-01-311250
K063158SYNTHES ANTEGRA SYSTEMSynthes Spine Co.Lp2006-11-14280
K053418SYNTHES OC FUSION SYSTEMSynthes Spine Co.Lp2006-09-062720
K061891SYNEX IISynthes Spine Co.Lp2006-08-18460
K053508SYNFIX-LRSynthes Spine Co.Lp2006-02-13590
K052151SYNTHES PANGEA MONOAXIAL SYSTEMSynthes Spine Co.Lp2005-12-071210
K050451SYNTHES VECTRA SYSTEMSynthes Spine Co.Lp2005-03-24303

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