SMV Scientific Cannulated Screws

Screw, Fixation, Bone

SMV Scientific

The following data is part of a premarket notification filed by Smv Scientific with the FDA for Smv Scientific Cannulated Screws.

Pre-market Notification Details

Device IDK170021
510k NumberK170021
Device Name:SMV Scientific Cannulated Screws
ClassificationScrew, Fixation, Bone
Applicant SMV Scientific 111 Sandra Muraida Way Unit 18A Austin,  TX  78703
ContactNephi Zufelt
CorrespondentKenneth C. Maxwell
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-03
Decision Date2017-05-22
Summary:summary

NIH GUDID Devices

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