FDA.reportPublic FDA data

Matrixx System

Primary DI
00889929068342
Brand
Matrixx System
Company
NEXXT SPINE, LLC
Model
62-2660-16-20-SP
Device description
Lateral, 26Wx60Lx16H 20°
Published
2025-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200969000NEXXT MATRIXX SystemNexxt Spine, LLC2020-05-21MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929068342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929068342008899290683428899290683420889929068342

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle20degree
Depth26Millimeter
Height16Millimeter
Width60Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
003489810
Device count
1
Lot or batch
true
Expiration date on label
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
00763000704452MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000704537MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000880897MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881153MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881382MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881399MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881405MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
18257200076871FORZAOrthofix US LLCMAX2026-07-17
18257200076888FORZAOrthofix US LLCMAX2026-07-17
18257200076895FORZAOrthofix US LLCMAX2026-07-17
18257200076901FORZAOrthofix US LLCMAX2026-07-17
18257200076918FORZAOrthofix US LLCMAX2026-07-17
18257200076925FORZAOrthofix US LLCMAX2026-07-17
18257200077007FORZAOrthofix US LLCMAX2026-07-17
18257200077038FORZAOrthofix US LLCMAX2026-07-17
18257200106028FORZAOrthofix US LLCMAX2026-07-17
18257200106035FORZAOrthofix US LLCMAX2026-07-17
18257200106042FORZAOrthofix US LLCMAX2026-07-17
18257200106066FORZAOrthofix US LLCMAX2026-07-17
18257200106073FORZAOrthofix US LLCMAX2026-07-17
18257200106080FORZAOrthofix US LLCMAX2026-07-17
18257200106097FORZAOrthofix US LLCMAX2026-07-17
18257200106103FORZAOrthofix US LLCMAX2026-07-17
18257200106141FORZAOrthofix US LLCMAX2026-07-17
18257200106158FORZAOrthofix US LLCMAX2026-07-17
18257200109432FORZA PTCOrthofix US LLCMAX2026-07-17
18257200136056FORZA XPOrthofix US LLCMAX2026-07-17
18257200136063FORZA XPOrthofix US LLCMAX2026-07-17
18257200136070FORZA XPOrthofix US LLCMAX2026-07-17
18257200151769FORZA TiOrthofix US LLCMAX2026-07-17