Facet Fixx™ Facet Screw System

FDA UDI

Class U (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name: Facet Fixx™ Facet Screw System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 45mm FDA UDI
Model / Reference: 14-12-5045 FDA UDI
Description: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 45mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00889929001363 FDA UDI
510(k) Number: K131417 FDA UDI
FDA Product Code: MRW FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 45 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

Facet Fixx Facet Screw System is a comprehensive spinal fixation solution designed to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. Made from non-bioabsorbable materials, it is available in various types including pedicle and transfacet with different drives.

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Also classified as Spinal bone screw, non-bioabsorbable.

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AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Nexxt Spine Llc

Sources (1)

FDA UDI d7f7570c-2c66-4cf6-b291-8e756a18b580 36 fields · synced Jul 30, 2026

Facet Fixx™ Facet Screw System

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)