MODUS 2.5 MANDIBULAR RECONSTRUCTION SET

Plate, Bone

MEDARTIS AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Modus 2.5 Mandibular Reconstruction Set.

Pre-market Notification Details

Device IDK992682
510k NumberK992682
Device Name:MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
ClassificationPlate, Bone
Applicant MEDARTIS AG 1601 TRAPELO RD. RESERVOIR PLACE Waltham,  MA  02451
ContactLinda Jalbert
CorrespondentLinda Jalbert
MEDARTIS AG 1601 TRAPELO RD. RESERVOIR PLACE Waltham,  MA  02451
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-10
Decision Date1999-11-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.