Wrist Hemiarthroplasty System

Prosthesis, Wrist, Carpal Lunate

ARTHROSURFACE, INC.

The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Wrist Hemiarthroplasty System.

Pre-market Notification Details

Device IDK141920
510k NumberK141920
Device Name:Wrist Hemiarthroplasty System
ClassificationProsthesis, Wrist, Carpal Lunate
Applicant ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
ContactDawn J Wilson
CorrespondentDawn J Wilson
ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
Product CodeKWN  
CFR Regulation Number888.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-16
Decision Date2014-12-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M5288W950016W0 K141920 000
M5288W153523W0 K141920 000
M5288W153517W0 K141920 000
M5288W152223W0 K141920 000
M5288W152217W0 K141920 000
M5288W123517W0 K141920 000
M5288W122217W0 K141920 000

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