PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM

Rod, Fixation, Intramedullary And Accessories

ELLIPSE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Ellipse Technologies, Inc. with the FDA for Precice Intramedullary Limb Lengthening System.

Pre-market Notification Details

Device IDK141023
510k NumberK141023
Device Name:PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ELLIPSE TECHNOLOGIES, INC. 13900 Alton Pkwy Ste 123 Irvine,  CA  92618
ContactRebecca Shelburne
CorrespondentRebecca Shelburne
ELLIPSE TECHNOLOGIES, INC. 13900 Alton Pkwy Ste 123 Irvine,  CA  92618
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-21
Decision Date2014-05-20
Summary:summary

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