XD880A Ultrasonic Osteotomy Surgical System

Instrument, Surgical, Sonic And Accessory/attachment

Morley Research Consortium

The following data is part of a premarket notification filed by Morley Research Consortium with the FDA for Xd880a Ultrasonic Osteotomy Surgical System.

Pre-market Notification Details

Device IDK172464
510k NumberK172464
Device Name:XD880A Ultrasonic Osteotomy Surgical System
ClassificationInstrument, Surgical, Sonic And Accessory/attachment
Applicant Morley Research Consortium Four Concourse Parkway Suite 215 Atlanta,  GA  30328
ContactSuzan Davis
CorrespondentSuzan Davis
Morley Research Consortium Four Concourse Parkway Suite 215 Atlanta,  GA  30328
Product CodeJDX  
CFR Regulation Number888.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-14
Decision Date2018-04-24
Summary:summary

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