Arthrosurface Bone Screws

Screw, Fixation, Bone

ARTHROSURFACE, INC.

The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Arthrosurface Bone Screws.

Pre-market Notification Details

Device IDK161539
510k NumberK161539
Device Name:Arthrosurface Bone Screws
ClassificationScrew, Fixation, Bone
Applicant ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
ContactDawn J. Wilson
CorrespondentDawn J. Wilson
ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-03
Decision Date2016-06-30
Summary:summary

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