M.U.S.T. Midline Cortical (MC) Screw System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 03.58.417Model Spine MUST screw (tulip)

by Medacta International

Identity

Trade Name: MUST MC Screw Ø4.5x55 EUDAMED
M.U.S.T. Midline Cortical (MC) Screw System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: MUST MC Screw Ø4.5x55 FDA UDI
Model / Reference: 03.58.417 EUDAMEDFDA UDI
Spine MUST screw (tulip) EUDAMED
Description: MUST MC Screw Ø4.5x55 FDA UDI

Identifiers

Primary DI / UDI-DI: 07630971294592 EUDAMEDFDA UDI
Basic UDI-DI: 764014274VIS0084R061YS EUDAMED
510(k) Number: K210427 FDA UDI
FDA Product Code: NKB FDA UDI
EMDN Code: P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Spinal bone screw, non-bioabsorbable

M.U.S.T. Midline Cortical (MC) Screw System by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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

K210427 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medacta International

Sources (2)

FDA UDI 41d2d9ce-4b13-4ff6-aa88-ba96e4060c5a 34 fields · synced Jul 31, 2026
EUDAMED b1f128ca-89cb-4823-b804-2b3b11f76c86 61 fields · synced Jul 31, 2026