OsteoMed ExtremiFix Mid And Large Screw System

Screw, Fixation, Bone

OsteoMed LLC

The following data is part of a premarket notification filed by Osteomed Llc with the FDA for Osteomed Extremifix Mid And Large Screw System.

Pre-market Notification Details

Device IDK163303
510k NumberK163303
Device Name:OsteoMed ExtremiFix Mid And Large Screw System
ClassificationScrew, Fixation, Bone
Applicant OsteoMed LLC 3885 Arapaho Rd Addison,  TX  75001
ContactEllen Hong
CorrespondentKathryn Jayne
OsteoMed LLC 3885 Arapaho Rd Addison,  TX  75001
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-22
Decision Date2017-04-04
Summary:summary

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