EUROPA™ Pedicle Screw

FDA UDI

Class II (US FDA UDI)

by Mirus Llc

Identity

Trade Name: EUROPA™ Pedicle Screw FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Ø6.5 X 70mm EUROPA™ MIS Pedicle Screw, Cannulated FDA UDI
Model / Reference: 1-1-6570C FDA UDI
Description: Ø6.5 X 70mm EUROPA™ MIS Pedicle Screw, Cannulated FDA UDI

Identifiers

Primary DI / UDI-DI: 00811638030235 FDA UDI
510(k) Number: K180337 FDA UDI
K182970 FDA UDI
FDA Product Code: NKB FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable 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

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

The EUROPA Pedicle Screw is a highly effective and reliable spinal fixation device designed for the treatment of spinal instabilities or deformities. This MIS pedicle screw, available in various types such as cannulated, features a unique drive system that securely fastens to bone, providing long-term stability and immobilization.

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
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

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: Mirus Llc

Sources (1)

FDA UDI 942115aa-a860-4937-a701-30d7e3d44fe0 34 fields · synced Jul 29, 2026