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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 16mm H x 14mm W x 30mm L x 0 degrees FDA UDI
Model / Reference
1 FDA UDI
Description
LLIF Sizing Trial 16mm H x 14mm W x 30mm L x 0 degrees FDA UDI

Identifiers

Catalog Number
TL161430 FDA UDI
Primary DI / UDI-DI
B587TL1614300 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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 — 30 Millimeter FDA UDI
Height — 16 Millimeter FDA UDI

Category: Spinal implant trial

The Yellowstone device is a reusable spinal implant trial used to validate the proper size of permanent implants, determine their appropriate position, and verify the correct implant site dimensions. It can be made of metal or plastic and is sterilized using Moist Heat or Steam Sterilization.

Similar devices

Also classified as Spinal implant trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Summit Spine

Sources (1)

  • FDA UDI c0329b81-18b0-4e09-9c40-7fabf167e1d5 36 fields · synced Jul 11, 2026