← Back to catalogue

Valeo Fusion System

FDA UDI

Class I (US FDA UDI)

by Amedica Corp.

Identity

Trade Name
Valeo Fusion System FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
Valeo Corpectomy Caliper FDA UDI
Model / Reference
B FDA UDI
Description
Valeo Corpectomy Caliper FDA UDI

Identifiers

Catalog Number
91.009.5510 FDA UDI
Primary DI / UDI-DI
M555910095510 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, single-use

Valeo Fusion System by Amedica Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Amedica Corp.

Sources (1)

  • FDA UDI 204591cf-2525-4dc8-ad58-2c7f3fe61fd9 35 fields · synced May 30, 2026