Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Etex Corp. — Predicate Candidate Screening

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

105 daysmedian FDA review time
403 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100883CARRIGENEtex Corp.2010-12-212660
K101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENEtex Corp.2010-07-01270
K093447CARRIGENEtex Corp.2010-02-181050
K091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEEtex Corp.2009-12-231950
K091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEEtex Corp.2009-11-021520
K090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTEEtex Corp.2009-09-181720
K090310EQUIVABONEEtex Corp.2009-03-24460
K090242GAMMA-BSM, BETA-BSMEtex Corp.2009-02-20180
K080329CAP PLUS, EQUIVABONE, CAP/DBMEtex Corp.2008-04-28810
K063050CAP PLUSEtex Corp.2007-11-194110
K072636A-BSM BONE SUBSTITUTE MATERIALEtex Corp.2007-10-23350
K072355OSSIFUSE BONE SUBSTITUTE MATERIALEtex Corp.2007-09-26350
K062630OSSIPRO BONE SUBSTITUTE MATERIALEtex Corp.2007-06-282960
K033138CAP3 BONE SUBSTITUTE MATERIALEtex Corp.2003-12-02630
K032307CAP BONE SUBSTITUTE MATERIALEtex Corp.2003-10-24910
K983009BSM- BONE SUBSTITUTE MATERIALEtex Corp.1998-11-25890
K962548BSM BONE SUBSTITUTE MATERIAL KITEtex Corp.1997-08-054030
K935696ETEX HA HIP REPLACEMENT SYSTEMEtex Corp.1994-07-222340

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