Fixone Biocomposite Interference Screw

FDA UDI

Class II (US FDA UDI)

by Aju Pharm. Co., Ltd.

Identity

Trade Name: Fixone Biocomposite Interference Screw FDA UDI
Generic Name: Bioabsorbable orthopaedic bone screw FDA UDI
Device Name: The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or softtissue grafts during anterior or posterior cruciate ligament reconstruction surgery. FDA UDI
Model / Reference: IAB-90025a FDA UDI
Description: The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or softtissue grafts during anterior or posterior cruciate ligament reconstruction surgery. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800039100229 FDA UDI
510(k) Number: K193497 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Bioabsorbable orthopaedic bone screw 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

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 Unsafe FDA UDI

Category: Bioabsorbable orthopaedic bone screw

Fixone Biocomposite Interference Screw by Aju Pharm. Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K193497 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: Aju Pharm. Co., Ltd.

Sources (1)

FDA UDI f225c9d3-1f27-4382-8ffe-0a19e58a5ec2 34 fields · synced May 31, 2026