FDA.reportPublic FDA data

Nextremity Solutions

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095407493009540749Nextremity Solutions1N2020-04-25210 N Buffalo St Warsaw IN US 46580

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1390381530615532K192578InCore TMT SystemHWC2019-12-31
1390381013143957K182201Stratum™ Foot Plating SystemHRS2018-11-16
1390381232766344K180257InCore® Lapidus SystemHWC2018-04-25
1390381693726820K152548AXI+LINE Proximal Bunion Correction SystemHRS2015-12-21
1390381581467616K151160Arcus Staple SystemJDR2015-09-04
1390381742055906K140724MSP METATARSAL SHORTENING SYSTEMHRS2014-05-14
1390381034563916K131061RESTORE BUNION CORRECTION SYSTEMJDR2013-08-28
1390381224727236K122031NEXTRA TI HAMMERTOE CORRECTION SYSTEMHWC2012-10-09
1390381490239065K110445FLEXFUSION (TM) FIXATION IMPLANTHWC2011-03-17
1390381372830153
1390381951840995

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC42019-12-31
HRS32018-11-16
JDR22015-09-04

PMN#

GUDID#

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