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: LLIF Sizing Trial 12mm H x 18mm W x 40mm L x 8 degrees FDA UDI
Model / Reference: 1 FDA UDI
Description: LLIF Sizing Trial 12mm H x 18mm W x 40mm L x 8 degrees FDA UDI

Identifiers

Catalog Number: TL121840-8 FDA UDI
Primary DI / UDI-DI: B587TL12184080 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 — 40 Millimeter FDA UDI
Height — 12 Millimeter FDA UDI
Angle — 8 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 52560d80-c87d-4c0e-af62-81f466361722 36 fields · synced May 31, 2026