Biointrafix

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: BIOINTRAFIX FDA UDI
Generic Name: Tendon/ligament bone anchor, bioabsorbable FDA UDI
Device Name: BIO-INTRAFIX Tibial Sheath, Large FDA UDI
Model / Reference: 254628 FDA UDI
Description: BIO-INTRAFIX Tibial Sheath, Large FDA UDI

Identifiers

Catalog Number: 254628 FDA UDI
Primary DI / UDI-DI: 10886705013241 FDA UDI
510(k) Number: K032167 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Tendon/ligament bone anchor, 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

Category: Tendon/ligament bone anchor, bioabsorbable

Biointrafix 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

Cleared under the same submission

K032167 also covers:

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 954f2654-e829-45a5-add9-2e5bf956fc39 36 fields · synced May 30, 2026