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Valeo Spacer System

FDA UDI

Class II (US FDA UDI)

by Amedica Corp.

Identity

Trade Name
Valeo Spacer System FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
Rasp, Directional, 17x14mm, 0°, 9mm FDA UDI
Model / Reference
A FDA UDI
Description
Rasp, Directional, 17x14mm, 0°, 9mm FDA UDI

Identifiers

Catalog Number
91.009.7309 FDA UDI
Primary DI / UDI-DI
M555910097309 FDA UDI
FDA Product Code
MAX FDA UDI
ODP FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use 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

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

Dimensions & Sizes

Size
Width — 14 Millimeter FDA UDI
Length — 17 Millimeter FDA UDI
Height — 9 Millimeter FDA UDI

Category: Internal spinal fixation procedure kit, single-use

Valeo Spacer System by Amedica Corp. — Class II — 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

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Manufacturer

Manufacturer
Amedica Corp.

Sources (1)

  • FDA UDI d2b2b7b7-d48d-49a9-8d81-1d883375e3dc 36 fields · synced May 30, 2026