Medyssey Spinal System - Rod

FDA UDI

Class II (US FDA UDI)

by Medyssey Co., Ltd.

Identity

Trade Name: Medyssey Spinal System - Rod FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Pre-Contoured Titanium Rod ,Ø6.35mm, Length 100mm FDA UDI
Model / Reference: BR63100 FDA UDI
Description: Pre-Contoured Titanium Rod ,Ø6.35mm, Length 100mm FDA UDI

Identifiers

Primary DI / UDI-DI: 08806364613335 FDA UDI
FDA Product Code: MNI FDA UDI
MNH 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

Medyssey Spinal System - Rod by Medyssey Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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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

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Manufacturer

Manufacturer: Medyssey Co., Ltd.

Sources (1)

FDA UDI a3233962-ece4-4a2b-a362-f550424f1c30 33 fields · synced Jun 1, 2026