FDA.reportPublic FDA data

PARADIGM SPINE, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057251103005725110PARADIGM SPINE, LLC1Y2020-04-25505 Park Avenue 14th Floor New York NY US 10022

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
938161377515037P110008COFLEX® INTERLAMINAR TECHNOLOGYNQO2012-10-17
938161367637472K153302coflex-IFPEK2016-09-08
938162046878038K112595COFLEX-FKWP2012-02-13
938161816530779K101083DSS STABILIZATION SYSTEMNQP2010-07-02
938161387814065K093438PARADIGM INTERSPINOUS FUSION PLATEKWP2010-10-06
938161739311056K091944MODIFICATION TO: DSS STABILIZATION SYSTEMNQP2009-08-03
938161309976814K090408MODIFICATION TO: DSS STABILIZATION SYSTEMNKB2009-03-20
938161792530214K090099DSS STABILIZATION SYSTEMNKB2009-06-19
938161002502337K080963DSS STABILIZATION SYSTEMNQP2008-05-02
938161710843454K080241DDS STABILIZATION SYSTEMNQP2008-11-28
938161965140550K072969DSSNQP2008-01-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQP52010-07-02
KWP22012-02-13
NKB22009-06-19
PEK12016-09-08
NQO12012-10-17

PMA#

PMN#

DSS

2008-01-24

PARADIGM SPINE, LLC

GUDID#

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