FDA.reportPublic FDA data

Struxxure® Plate System

Primary DI
00889929072639
Brand
Struxxure® Plate System
Company
NEXXT SPINE, LLC
Model
63-60T-20
Device description
Ø6.0mm Lumbar Screw THR, 20mm
Published
2026-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202192000STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC2020-09-17KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929072639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929072639008899290726398899290726390889929072639

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Outer Diameter6Millimeter

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
00840067212189TrellOss®-A SA432H00142026-06-24
00840067212196TrellOss®-A SA432H00192026-06-24
00840067212202TrellOss®-A SA432H00202026-06-24
00840067212219TrellOss®-A SA432H00212026-06-24
00840067212226TrellOss®-A SA432H00222026-06-24
00840067212233TrellOss®-A SA432H00232026-06-24
00840067212240TrellOss®-A SA432H00242026-06-24
00840067212257TrellOss®-A SA432H01082026-06-24
00840067212264TrellOss®-A SA432H01102026-06-24
00840067212271TrellOss®-A SA432H01122026-06-24
00840067212288TrellOss®-A SA432H01142026-06-24
00840067212295TrellOss®-A SA432H01162026-06-24
00840067212301TrellOss®-A SA432H01182026-06-24
00840067212318TrellOss®-A SA432H01202026-06-24
00889929072752NEXXT MATRIXX® Stand Alone ALIF SystemI61-03-022026-06-24
00889929072769NEXXT MATRIXX® Stand Alone ALIF SystemI61-20-072026-06-24
00889929072776NEXXT MATRIXX® Stand Alone ALIF SystemI61-20-082026-06-24
00889929072783NEXXT MATRIXX® Stand Alone ALIF SystemI61-22-062026-06-24
00889929072424Matrixx SystemI92-20-022026-05-27
00889929072523Struxxure® Plate System63-55T-152026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916450Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00193982572983CREOGLOBUS MEDICAL, INC.KWQ2026-06-10
00840493423531RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00840493423548RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00840493423555RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00841732150911PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWQ2023-09-09
00841732150928PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWQ2023-09-09
B6785211900PreView II™NEXUS SPINE, L.L.C.KWQ2021-12-17
B6785211910PreView II™NEXUS SPINE, L.L.C.KWQ2021-12-17
10889981142117MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142124MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142148MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142155MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142179MarinerSeaspine Orthopedics CorporationKWQ2021-10-02