Zenius Spinal System

FDA UDI

Class II (US FDA UDI)

by Medyssey Co., Ltd.

Identity

Trade Name: Zenius Spinal System FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: MIS Variable Rod, Ø5.5mm X 90mm FDA UDI
Model / Reference: VR55090 FDA UDI
Description: MIS Variable Rod, Ø5.5mm X 90mm FDA UDI

Identifiers

Primary DI / UDI-DI: 08809547360149 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system rod

Learn about the Zenius Spinal System, a cutting-edge bone-screw internal spinal fixation system designed to provide immobilization and stabilization of spinal segments for various spinal instabilities or deformities. This implantable component is made up of a thin cylinder, available in different forms and with varying diameters, allowing for flexibility and small movements of the spine.

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medyssey Co., Ltd.

Sources (1)

FDA UDI fb2af070-abc2-4fd4-97b2-cdbe4a48ab68 33 fields · synced Jul 9, 2026