FDA.reportPublic FDA data

TrellOss®-MCP

Primary DI
00840067211953
Brand
TrellOss®-MCP
Company
NEXXT SPINE, LLC
Model
115N8408
Device description
MCP SD Screw Var 4x18 THR
Published
2026-04-22
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
K133475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133475000STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSNexxt Spine, LLC2013-12-19KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067211953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067211953008400672119538400672119530840067211953

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Outer Diameter4Millimeter

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
00889929072424Matrixx SystemI92-20-022026-05-27
00889929072523Struxxure® Plate System63-55T-152026-05-14
00889929072530Struxxure® Plate System63-55T-202026-05-14
00889929072547Struxxure® Plate System63-55T-252026-05-14
00889929072554Struxxure® Plate System63-55T-302026-05-14
00889929072561Struxxure® Plate System63-55T-352026-05-14
00889929072578Struxxure® Plate System63-55T-402026-05-14
00889929072585Struxxure® Plate System63-55T-452026-05-14
00889929072592Struxxure® Plate System63-55T-502026-05-14
00889929072608Struxxure® Plate System63-55T-552026-05-14
00889929072615Struxxure® Plate System63-55T-602026-05-14
00889929072622Struxxure® Plate System63-60T-152026-05-14
00889929072639Struxxure® Plate System63-60T-202026-05-14
00889929072646Struxxure® Plate System63-60T-252026-05-14
00889929072653Struxxure® Plate System63-60T-302026-05-14
00889929072660Struxxure® Plate System63-60T-352026-05-14
00889929072677Struxxure® Plate System63-60T-402026-05-14
00889929072684Struxxure® Plate System63-60T-452026-05-14
00889929072691Struxxure® Plate System63-60T-502026-05-14
00889929072707Struxxure® Plate System63-60T-552026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986492791CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
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00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
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00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
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00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
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00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
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