Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based Software

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Smith & Nephew, Inc

The following data is part of a premarket notification filed by Smith & Nephew, Inc with the FDA for Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based Software.

Pre-market Notification Details

Device IDK142520
510k NumberK142520
Device Name:Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based Software
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Smith & Nephew, Inc 1450 Brooks Road Memphis,  TN  38116
ContactMartin Ostmann
CorrespondentMartin Ostmann
Smith & Nephew, Inc 1450 Brooks Road Memphis,  TN  38116
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-08
Decision Date2014-11-20
Summary:summary

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