FDA.report

Curonix

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30106761383010676138CURONIX LLC1N2026-01-011310 Park Central Boulevard S Pompano Beach FL US 33064

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3149151912300299K233162Freedom Peripheral Nerve Stimulator (PNS) SystemGZF2024-06-20
3149151371131468K191466SandShark Injectable Anchor (SIA) SystemGZB2019-11-07
3149151565046729K182720Freedom Spinal Cord Stimulator (SCS) SystemGZB2019-03-29
3149151765149332K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB2018-09-19
3149151378550044K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseGZB2017-11-03
3149151582977329K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitGZF2017-08-04
3149151656990773K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitGZB2017-05-02
3149151380981332K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitGZB2016-12-16
3149151117420787K160600Freedom Spinal Cord Stimulator SystemGZB2016-08-26
3149151886420198K152178StimQ Peripheral Nerve Stimulator (PNS) SystemGZF2016-03-11
3149151838038593K150517Freedom Spinal Cord Stimulator SystemGZB2015-06-05
3149151965300501K141399FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEMGZB2014-10-10

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GZB92019-11-07
GZF32024-06-20

PMN

GUDID

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