Rexious

FDA UDI

Class II (US FDA UDI)

by Dio Medical Co., Ltd.

Identity

Trade Name: Rexious FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: Poly-Axial Cannulated Pedicle C Type (Double & Self Tapping) (L1)70x(L2)6.5x(A)15.8x(B)12.5x(C)1.6mm-Ø5.5 FDA UDI
Model / Reference: A FDA UDI
Description: Poly-Axial Cannulated Pedicle C Type (Double & Self Tapping) (L1)70x(L2)6.5x(A)15.8x(B)12.5x(C)1.6mm-Ø5.5 FDA UDI

Identifiers

Catalog Number: FX.CS.6570 FDA UDI
Primary DI / UDI-DI: 08800113946088 FDA UDI
510(k) Number: K173080 FDA UDI
FDA Product Code: ODP FDA UDI
MAX FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Rexious by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Dio Medical Co., Ltd.

Sources (1)

FDA UDI 19d85a91-7636-4fdb-8ee1-d4df539c8d77 36 fields · synced Jun 6, 2026