Medyssey Poseidon OCT Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by Medyssey Co., Ltd.

Identity

Trade Name: Medyssey Poseidon OCT Spinal Fixation System FDA UDI
Generic Name: Vertebral body prosthesis, non-sterile FDA UDI
Device Name: Poseidon Reduction Smooth Shank Poly-Axial Screw, 4.5X56mm, 3.5mm rod FDA UDI
Model / Reference: RPPS4556 FDA UDI
Description: Poseidon Reduction Smooth Shank Poly-Axial Screw, 4.5X56mm, 3.5mm rod FDA UDI

Identifiers

Primary DI / UDI-DI: 08809596878800 FDA UDI
FDA Product Code: KWP FDA UDI
NKG FDA UDI
GMDN Term: Vertebral body prosthesis, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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: Vertebral body prosthesis, non-sterile

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

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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 a0fec7fd-7a6c-4319-87f1-816d1e15866e 33 fields · synced May 30, 2026