Biofoam

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: BIOFOAM FDA UDI
Generic Name: Metallic osteotomy fusion cage, non-customized FDA UDI
Model / Reference: 46S42012 FDA UDI

Identifiers

Catalog Number: 46S42012 FDA UDI
Primary DI / UDI-DI: 00840420135704 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Metallic osteotomy fusion cage, non-customized FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 12 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI
Width — 20 Millimeter FDA UDI

Category: Metallic osteotomy fusion cage, non-customized

Biofoam by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Wright Medical Technology, Inc.

Sources (1)

FDA UDI e35b5067-9b6f-422d-a037-466aef4ebd12 35 fields · synced Jun 8, 2026