Yellowstone

FDA UDI

Class II (US FDA UDI)

by Summit Spine

Identity

Trade Name: Yellowstone FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: 6mm H x 18mm W x 65mm L XLIF Trial 12 degree Lordosis FDA UDI
Model / Reference: 1 FDA UDI
Description: 6mm H x 18mm W x 65mm L XLIF Trial 12 degree Lordosis FDA UDI

Identifiers

Catalog Number: L061865-12 FDA UDI
Primary DI / UDI-DI: B587L061865120 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Spinal implant trial 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

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 18 Millimeter FDA UDI
Length — 65 Millimeter FDA UDI
Height — 6 Millimeter FDA UDI
Angle — 12 degree FDA UDI

Category: Spinal implant trial

Yellowstone by Summit Spine — 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: Summit Spine

Sources (1)

FDA UDI 771f268c-26e3-4b51-a929-d0df8a165c64 36 fields · synced May 31, 2026