Intrafix

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: INTRAFIX FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: INTRAFIX Advance Tibial Fastener System Screw 12 x 30mm PEEK FDA UDI
Model / Reference: 254841 FDA UDI
Description: INTRAFIX Advance Tibial Fastener System Screw 12 x 30mm PEEK FDA UDI

Identifiers

Catalog Number: 254841 FDA UDI
Primary DI / UDI-DI: 10886705027460 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Tendon/ligament bone 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Intrafix by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tendon/ligament bone anchor, non-bioabsorbable.

Hi-Fi — Conmed Corporation · Class II
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Ecobone — Bonegraft Biomaterials Co. · Class III
fX — Bonegraft Biomaterials Co. · Class III
GII PANACRYL — DePuy Mitek, Inc. · Class II
Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, 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: Medos International Sàrl

Sources (1)

FDA UDI 6a570a3c-7d35-49b3-bff3-0323b9835ffd 35 fields · synced Jun 1, 2026