FairFix Adjustable Button System

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: FairFix Adjustable Button System FDA UDI
Generic Name: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Device Name: FairFix QT Adjustable Button FDA UDI
Model / Reference: 05.05.0124 FDA UDI
Description: FairFix QT Adjustable Button FDA UDI

Identifiers

Primary DI / UDI-DI: 07630345795144 FDA UDI
510(k) Number: K223795 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Soft-tissue/mesh anchor, non-bioabsorbable

FairFix Adjustable Button System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Medacta International

Sources (1)

FDA UDI c3c3ef09-9614-4ac7-89b4-b4dcde7c7c1a 34 fields · synced May 30, 2026