Intrafix

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: INTRAFIX FDA UDI
Generic Name: Tendon/ligament bone anchor, bioabsorbable FDA UDI
Device Name: INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Small 8 x 30mm BR FDA UDI
Model / Reference: 254807 FDA UDI
Description: INTRAFIX Advance Tibial Fastener System BIOCRYL RAPIDE Sheath and Screw Small 8 x 30mm BR FDA UDI

Identifiers

Catalog Number: 254807 FDA UDI
Primary DI / UDI-DI: 10886705026739 FDA UDI
FDA Product Code: MAI FDA UDI
GMDN Term: Tendon/ligament bone anchor, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 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, 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, bioabsorbable.

Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
5 x 15mm CitreLock Implant — ACUITIVE TECHNOLOGIES · Class II
Fix2Lock — OSTEONIC CO., Ltd. · Class II
Fixone Hybrid Anchor — AJU PHARM. CO., LTD. · Class II
Arthrex® — Arthrex, Inc. · Class II
Twist — PARCUS MEDICAL LLC · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medos International Sàrl

Sources (1)

FDA UDI d12384b1-000f-4625-b286-3e4a74976614 36 fields · synced May 29, 2026