FDA.reportPublic FDA data

Facet Fixx™ Facet Screw System

Primary DI
00889929024942
Brand
Facet Fixx™ Facet Screw System
Company
NEXXT SPINE, LLC
Model
14-11-6040
Device description
Facet Fixx, Screw, Full Thread, Ø6.0 x 40mm
Published
2017-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131417000FACET FIXXNexxt Spine, LLC2013-07-12MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929024942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929024942008899290249428899290249420889929024942

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used 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 (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
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
00889929072943Inertia® Pedicle Screw SystemI10-05-06M2026-08-26
00889929072929HONOUR® Spacer SystemI21-01-042026-07-29
00889929072936HONOUR® Spacer SystemI21-01-052026-07-29
00889929072820Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95602026-07-20
00889929072837Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95652026-07-20
00889929072844Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95702026-07-20
00889929072851Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95752026-07-20
00889929072868Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95802026-07-20
00889929072875Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95852026-07-20
00889929072882Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95902026-07-20
00889929072899Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95952026-07-20
00889929072905Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-951052026-07-20
00889929072912Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-951152026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131885045ION Non CervicalSurgentec, LLCMRW2026-07-28
00810131882761Facet Sterile Implant - 55Surgentec, LLCMRW2026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalSurgentec, LLCMRW2026-07-06
00810131884772ION-C Final KitSurgentec, LLCMRW2026-07-06
00810131884895ION-C ReusableSurgentec, LLCMRW2026-07-06
00810131881795ION Disposable Instrument KitSurgentec, LLCMRW2026-03-09
00810131881801ION 55 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
00810131881818ION 60 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
00810131881825ION 65 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
00840916160135SPARTANSPINAL ELEMENTSMRW2020-12-07
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08800039820035FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
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