ELLIPSE 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 Ellipse Precice Intramedullary Limb Lengthening System.

Pre-market Notification Details

Device IDK113219
510k NumberK113219
Device Name:ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ELLIPSE TECHNOLOGIES, INC. 13900 Alton Pkwy Ste 123 Irvine,  CA  92618
ContactJohn Mclntyre
CorrespondentJohn Mclntyre
ELLIPSE TECHNOLOGIES, INC. 13900 Alton Pkwy Ste 123 Irvine,  CA  92618
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-01
Decision Date2012-10-19
Summary:summary

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