FDA.reportPublic FDA data

TrellOss®

Primary DI
00840067208564
Brand
TrellOss®
Company
NEXXT SPINE, LLC
Model
110N1606
Device description
TrellOss-C 16Dx18Wx6H 10°
Published
2025-07-29
Public version status
New
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
MQPSpinal Vertebral Body Replacement Device
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171140000Matrixx SystemNexxt Spine, LLC2017-08-22ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067208564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067208564008400672085648400672085640840067208564

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle10degree
Depth16Millimeter
Height6Millimeter
Width18Millimeter

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
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
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

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