PRECICE Trauma Nail System

Rod, Fixation, Intramedullary And Accessories

Ellipse Technologies Incorporated

The following data is part of a premarket notification filed by Ellipse Technologies Incorporated with the FDA for Precice Trauma Nail System.

Pre-market Notification Details

Device IDK152370
510k NumberK152370
Device Name:PRECICE Trauma Nail System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Ellipse Technologies Incorporated 13900 Alton Parkway Ste 123 Irvine,  CA  92618
ContactJohn Mcintyre
CorrespondentJohn Mcintyre
Ellipse Technologies Incorporated 101 Enterprise Suite 100 Aliso Viejo,  CA  92656
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-21
Decision Date2015-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812258028329 K152370 000
00812258022730 K152370 000

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