ARTHROSURFACE TOEMOTION

Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained

ARTHROSURFACE, INC.

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

Pre-market Notification Details

Device IDK132496
510k NumberK132496
Device Name:ARTHROSURFACE TOEMOTION
ClassificationProsthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Applicant ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
ContactDawn J Wilson
CorrespondentDawn J Wilson
ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin,  MA  02038
Product CodeLZJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-09
Decision Date2014-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M5289P15S180A0 K132496 000
M5289P15PB02A0 K132496 000
M5289P15PB01A0 K132496 000
M5289P15PA02A0 K132496 000
M5289P15PA01A0 K132496 000
M5289P1501000 K132496 000

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