FDA.reportPublic FDA data

Nexxt Spine Navigation System

Primary DI
00889929072110
Brand
Nexxt Spine Navigation System
Company
NEXXT SPINE, LLC
Model
I64NAV-15-01
Device description
Navigated IMPAXX SI Inserter
Published
2025-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220291000NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC2022-03-31OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929072110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929072110008899290721108899290721100889929072110

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
317-436-7801Support@nexxtspine.com

Regulatory Flags#

DUNS number
003489810
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889929072219NEXXT MATRIXX® SI SystemI64-05-072026-07-17
00889929072226NEXXT MATRIXX® SI SystemI64-05-082026-07-17
00889929072233NEXXT MATRIXX® SI SystemI64-05-092026-07-17
00889929072264NEXXT MATRIXX® SI SystemI64-05-312026-07-17
00889929072271NEXXT MATRIXX® SI SystemI64-08-112026-07-17
00889929072288NEXXT MATRIXX® SI SystemI64-20-042026-07-17
00889929072295NEXXT MATRIXX® SI SystemI64-25-012026-07-17
00889929072301NEXXT MATRIXX® SI SystemI64-25-022026-07-17
00889929072318NEXXT MATRIXX® SI SystemI64-25-032026-07-17
00889929072325NEXXT MATRIXX® SI SystemI64-25-042026-07-17
00889929072332NEXXT MATRIXX® SI SystemI64-25-052026-07-17
00889929072349Matrixx SystemI92-20-042026-07-17
00889929072356NEXXT MATRIXX® SI SystemI64-05-322026-07-17
00889929072363NEXXT MATRIXX® SI SystemI64-05-332026-07-17
00889929072394NEXXT MATRIXX® SI SystemI64-05-342026-07-17
00889929072448Matrixx SystemI91-20-022026-07-17
00889929072745NEXXT MATRIXX® SI SystemI64-15-072026-07-17
00889929060209Inertia® CONNEXX™ Modular Pedicle Screw System20-SCC-85852024-12-18
00889929072400NEXXT MATRIXX® SI SystemC64-01-032026-07-10
00889929072738NEXXT MATRIXX® SI SystemI64-15-082026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000914035Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914042Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914059Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914066Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914073Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914080Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000953805Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
18257200140367NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140374NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140381NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140398NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140404NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140411NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140428NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140435NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140442NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140459NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140466NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140473NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140527FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140534FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140558FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140565FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140572FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140596FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140602FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140619FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140626FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140633FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140657FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17