Arcadius® Xp L

FDA UDI

Class II (US FDA UDI)

by Aesculap Implant Systems, Inc.

Identity

Trade Name: ARCADIUS® XP L FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: ARCADIUS COMPRESSION BONE SCREW 25 MM FDA UDI
Model / Reference: ME177T FDA UDI
Description: ARCADIUS COMPRESSION BONE SCREW 25 MM FDA UDI

Identifiers

Catalog Number: ME177T FDA UDI
Primary DI / UDI-DI: 04046964860799 FDA UDI
FDA Product Code: OVD FDA UDI
GMDN Term: Spinal bone screw, 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone screw, non-bioabsorbable

Arcadius® Xp L by Aesculap Implant Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Spinal bone screw, non-bioabsorbable.

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OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
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 II	Pending data

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Manufacturer

Manufacturer: Aesculap Implant Systems, Inc.

Sources (1)

FDA UDI b84bfcf9-befd-4c0a-ac94-d4b3505af89e 36 fields · synced Jun 1, 2026