Atlas FDA

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

Medicon EG — Predicate Candidate Screening

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

113 daysmedian FDA review time
280 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161680MEDICON Spinal Spreading SystemsMedicon EG2017-03-242800
K100916MEDICON MOGEN CLAMPMedicon EG2010-12-062480
K083803FIXIT HEADREST CLAMP SYSTEMMedicon EG2010-03-104430
K053624MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEMMedicon EG2006-07-172010
K050478MEDICON IMF-ORION SCREWSMedicon EG2005-06-151110
K043297MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEMMedicon EG2005-02-23860
K042974MEDICON VIPAIR HIGH SPEED SYSTEMMedicon EG2005-01-13770
K041527AARHUS ANCHORAGE SYSTEMMedicon EG2004-08-19720
K010910MEDICON YASARGIL CLIP APPLYING FORCEPSMedicon EG2001-08-011280
K010908MEDICON TITANIUM YASARGIL ANEURYSM CLIPSMedicon EG2001-08-011280
K972857SERVOTRONIC EC100 SYSTEMMedicon EG1998-01-161680
K970256INTRAORAL MANDIBULAR DISTRACTION DEVICEMedicon EG1997-03-11470
K951689TITANIUM MANDIBULAT RECONSTRUCTION SYSTEMMedicon EG1995-07-271130
K951687MESH TITANIUM IMPLANT SYSTEMMedicon EG1995-07-271130
K951690TITANIUM MINIPLATE SYSTEMMedicon EG1995-07-261120
K951688MICRO TITANIUM PLATE SYSTEMMedicon EG1995-07-261120
K951691CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEMMedicon EG1995-07-261120

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