FDA.reportPublic FDA data

NEXXT MATRIXX® SI System

Primary DI
00889929054833
Brand
NEXXT MATRIXX® SI System
Company
NEXXT SPINE, LLC
Model
I92-10-14
Device description
Square Power Adapter, Ø3.4 Cann.
Published
2025-05-16
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929054833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929054833008899290548338899290548330889929054833

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
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
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03