Biosteon® Screw

FDA UDI

Class II (US FDA UDI)

by Biocomposites Ltd

Identity

Trade Name: Biosteon® Screw FDA UDI
Generic Name: Bioabsorbable orthopaedic bone screw FDA UDI
Device Name: The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-latic) Acid and calcium phosphate which will be gradually resorbed into the body. This function however, is patient dependent. FDA UDI
Model / Reference: 234-010-170 FDA UDI
Description: The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-latic) Acid and calcium phosphate which will be gradually resorbed into the body. This function however, is patient dependent. FDA UDI

Identifiers

Catalog Number: 234-010-170 FDA UDI
Primary DI / UDI-DI: 15060155711239 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

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

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 23 Millimeter FDA UDI
Width — 10 Millimeter FDA UDI

Category: Bioabsorbable orthopaedic bone screw

Biosteon® Screw by Biocomposites Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bioabsorbable orthopaedic bone screw.

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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: Biocomposites Ltd

Sources (1)

FDA UDI 075ed0d8-dbd2-48de-aa6e-96a1f5a9f096 37 fields · synced Jun 1, 2026