FDA.reportPublic FDA data

Struxxure® Plate System

Primary DI
00889929072721
Brand
Struxxure® Plate System
Company
NEXXT SPINE, LLC
Model
I63-21-06
Device description
Screw Inserter THR
Published
2026-05-14
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
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
00889929072721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929072721008899290727218899290727210889929072721

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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
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