Valeo Fusion System

FDA UDI

Class II (US FDA UDI)

by Amedica Corp.

Identity

Trade Name: Valeo Fusion System FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: Valeo PL,9x21, 6°, 8mm FDA UDI
Model / Reference: B FDA UDI
Description: Valeo PL,9x21, 6°, 8mm FDA UDI

Identifiers

Catalog Number: 11.004.1608 FDA UDI
Primary DI / UDI-DI: M555110041608 FDA UDI
FDA Product Code: ODP FDA UDI
MAX FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 8 Millimeter FDA UDI
Width — 21 Millimeter FDA UDI
Length — 9 Millimeter FDA UDI

Category: Vertebral body prosthesis

Valeo Fusion System by Amedica Corp. — 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: Amedica Corp.

Sources (1)

FDA UDI 1bb78483-d273-4220-9ead-1e2e0dd64161 36 fields · synced Jun 6, 2026