Yellowstone - 18mm H x 24mm W x 65mm L x 12 degree Lateral - SUMMIT SPINE LLC

Duns Number:079539689

Device Description: 18mm H x 24mm W x 65mm L x 12 degree Lateral Implant

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More Product Details

Catalog Number

XL182465-12

Brand Name

Yellowstone

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

30b5c0d1-756f-4eab-a427-f36e694ceae7

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

August 02, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUMMIT SPINE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6658