FDA.reportPublic FDA data

NEXXT SPINE LLC

Matched from indexed company URL: Nexxt Spine

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30079225093007922509NEXXT SPINE LLC1N2026-01-0114425 Bergen Blvd Suite B Noblesville IN US 46060

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00889929072424Matrixx System - Implant Extractor317-436-7801Support@nexxtspine.com
00889929072523Struxxure® Plate System - Ø5.5mm Lumbar Screw THR, 15mm317-436-7801Support@nexxtspine.com
00889929072530Struxxure® Plate System - Ø5.5mm Lumbar Screw THR, 20mm317-436-7801Support@nexxtspine.com
00889929072547Struxxure® Plate System - Ø5.5mm Lumbar Screw THR, 25mm317-436-7801Support@nexxtspine.com
00889929072554Struxxure® Plate System - Ø5.5mm Lumbar Screw THR, 30mm317-436-7801Support@nexxtspine.com
00889929072561Struxxure® Plate System - Ø5.5mm Lumbar Screw THR, 35mm317-436-7801Support@nexxtspine.com
00889929072578Struxxure® Plate System - Ø5.5mm Lumbar Screw THR, 40mm317-436-7801Support@nexxtspine.com
00889929072585Struxxure® Plate System - Ø5.5mm Lumbar Screw THR, 45mm317-436-7801Support@nexxtspine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1091151142232597K243838NEXXT MATRIXX® SI SystemOUR2025-03-14
1091151219662570K240690STRUXXURE® MCS Anterior Cervical Plate SystemKWQ2024-03-22
1091151708690062K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNKB2023-07-20
1091151467622273K221905INERTIA CONNEXX Modular Pedicle Screw SystemNKB2022-07-28
1091151878408658K220291NEXXT SPINE NAVIGATION SystemOLO2022-03-31
1091151079331283K202230NEXXT MATRIXX Stand Alone ALIF SystemOVD2020-12-15
1091151820196738K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemKWQ2020-09-17
1091151696897602K200969NEXXT MATRIXX SystemMAX2020-05-21
1091151229235833K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemOVE2020-03-23
1091151928412425K193412NEXXT MATRIXX SystemPLR2020-02-24
1091151521864898K193370Nexxt Matrixx SystemMAX2020-01-21
1091151969238117K192687TrellOss™-L MPFMAX2020-01-09
1091151913062328K191408Nexxt Matrixx SystemMAX2019-07-10
1091151347864811K190546NEXXT MATRIXX Stand Alone Cervical SystemOVE2019-05-31
1091151568445009K182508Saxxony™ Posterior Cervical Thoracic SystemNKG2018-11-13
1091151807113959K171140Matrixx SystemODP2017-08-22
1091151562206203K153453Inertia Pedicle Screw and Deformity Correxxion SystemNKB2016-04-26
1091151705955476K141376INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSMNH2014-06-26
1091151671154061K133475STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSKWQ2013-12-19
1091151116326811K132412INERTIA MIS PEDICLE SCREW SYSTEMMNI2013-10-10
1091151076707608K131417FACET FIXXMRW2013-07-12
1091151711066268K120345HONOUR SPACER SYSTEMODP2012-06-13
1091151712170589K101278INERTIA PEDICLE SCREW SYSTEMMNH2010-12-20
1091151981175391K091936BLADE ANTERIOR CERVICAL PLATE SYSTEMKWQ2010-01-19
1091152019587937K090984INERTIA PEDICLE SCREW SYSTEMMNI2009-06-30
1091151099687837
1091151952972102
1091152000041852

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ42024-03-22
MAX42020-05-21
NKB32023-07-20
OVE22020-03-23
ODP22017-08-22
MNH22014-06-26
MNI22013-10-10
OUR12025-03-14
OLO12022-03-31
OVD12020-12-15
PLR12020-02-24
NKG12018-11-13
MRW12013-07-12

PMN#

GUDID#

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