FDA.reportPublic FDA data

NEXXT MATRIXX® SI System

Primary DI
00889929059050
Brand
NEXXT MATRIXX® SI System
Company
NEXXT SPINE, LLC
Model
C64-02-01
Device description
HELIXX SI Modular Washer Caddy
Published
2025-04-24
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
HWCScrew, Fixation, Bone
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243838000NEXXT MATRIXX® SI SystemNexxt Spine2025-03-14OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929059050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929059050008899290590508899290590500889929059050

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCHWC2026-07-17
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
07613327646825NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646832NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646849NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646856NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646863NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646870NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646887NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646894NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646900NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646917NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646931NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646948NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646955NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646962NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646979NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646986NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646993NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647006NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647013NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647020NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647037NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647044NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647051NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143375Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143382Firebird SI FusionOrthofix US LLCOUR2026-07-17