OsteoMed ExtremiFix Mini & Small System Tray

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

OsteoMed LLC

The following data is part of a premarket notification filed by Osteomed Llc with the FDA for Osteomed Extremifix Mini & Small System Tray.

Pre-market Notification Details

Device IDK202105
510k NumberK202105
Device Name:OsteoMed ExtremiFix Mini & Small System Tray
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant OsteoMed LLC 3885 Arapaho Road Addison,  TX  75001
ContactAndrew Johnson
CorrespondentAndrew Johnson
OsteoMed LLC 3885 Arapaho Road Addison,  TX  75001
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-29
Decision Date2020-10-29

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