M.U.S.T. Combined Set Screw

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 03.50.204Model Spine MUST setscrew

by Medacta International

Identity

Trade Name: MUST Combined Setscrew H4-T27 - (4x) EUDAMED
M.U.S.T. Combined Set Screw FDA UDI
Generic Name: Spinal bone set screw FDA UDI
Device Name: MUST Combined Setscrew H4-T27 - (4x) FDA UDI
Model / Reference: 03.50.204 EUDAMEDFDA UDI
Spine MUST setscrew EUDAMED
Description: MUST Combined Setscrew H4-T27 - (4x) FDA UDI

Identifiers

Primary DI / UDI-DI: 07630040716086 EUDAMEDFDA UDI
Basic UDI-DI: 764014274VIS0024R061WC EUDAMED
510(k) Number: K171758 FDA UDI
FDA Product Code: KWP FDA UDI
KWQ FDA UDI
NKB FDA UDI
EMDN Code: P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term: Spinal bone set screw FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3060 FDA UDI
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 set screw

M.U.S.T. Combined Set Screw by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Spinal bone set screw.

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Cleared under the same submission

K171758 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 a5f61a90-c100-4319-96fd-2b66c1abcd5c 34 fields · synced Jul 26, 2026
EUDAMED a9a4ba13-8e71-4c6f-82ed-135f50a3711d 61 fields · synced Jul 26, 2026