RESIDUAL 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 Residual Limb Lengthening System.

Pre-market Notification Details

Device IDK141739
510k NumberK141739
Device Name:RESIDUAL LIMB LENGTHENING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ELLIPSE TECHNOLOGIES INC. 13900 ALTON PKWY STE 123 Irvine,  CA  92618 -0000
ContactRebecca Shelburne
CorrespondentRebecca Shelburne
ELLIPSE TECHNOLOGIES INC. 13900 ALTON PKWY STE 123 Irvine,  CA  92618 -0000
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-27
Decision Date2014-10-07
Summary:summary

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