FDA.reportPublic FDA data

Nexxt Spine Navigation System

Primary DI
00889929059265
Brand
Nexxt Spine Navigation System
Company
NEXXT SPINE, LLC
Model
I12NAV-100
Device description
Navigated Awl
Published
2024-12-12
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
00889929059265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929059265008899290592658899290592650889929059265

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
00889929072943Inertia® Pedicle Screw SystemI10-05-06M2026-08-26
00889929072929HONOUR® Spacer SystemI21-01-042026-07-29
00889929072936HONOUR® Spacer SystemI21-01-052026-07-29
00889929072820Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95602026-07-20
00889929072837Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95652026-07-20
00889929072844Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95702026-07-20
00889929072851Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95752026-07-20
00889929072868Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95802026-07-20
00889929072875Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95852026-07-20
00889929072882Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95902026-07-20
00889929072899Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95952026-07-20
00889929072905Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-951052026-07-20
00889929072912Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-951152026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150067633Stealth AXiS Advanced Spine Referencing KitMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
04056481146429Automatic RegsitrationBrainlab SEOLO2026-02-20
00810180350051ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350099ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350112ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
006283415213837D Surgical Universal Array (5)7D Surgical ULCOLO2025-07-28
006283415213907D Surgical Universal Array (6)7D Surgical ULCOLO2025-07-28
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
04056481146320Alignment Software SpineBrainlab SEOLO2025-06-16
00850042604311Paradigm Drill Guide TrocarProprio, Inc.OLO2025-06-09
00810180350266ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350433ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350525ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350556ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350563ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350693ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00850030914347SkyWalkerMicroport Navibot International LLCOLO2025-04-24
00850030914354SkyWalkerMicroport Navibot International LLCOLO2025-04-24