FDA.reportPublic FDA data

NEXXT MATRIXX® SI System

Primary DI
00889929072400
Brand
NEXXT MATRIXX® SI System
Company
NEXXT SPINE, LLC
Model
C64-01-03
Device description
Matrixx SI Instrument Case
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929072400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929072400008899290724008899290724000889929072400

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00889929072301NEXXT MATRIXX® SI SystemI64-25-022026-07-17

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Primary DI, Brand, Company table
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00840606192019Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192026Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192033Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192040Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194884Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194891Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194907Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194914Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194921Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194938Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194945Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194952Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194969Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194976Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194983Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194990Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
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00840606195010Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
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00840606195034Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195041Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195058Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195065Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195539Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195669Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
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00840606195683Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195690Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195706Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31