Catalog Number

10-55-PR-100

Brand Name

Streamline TL Spinal Fixation System

Version/Model Number

10-55-PR-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K140696,K140696

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Public Device Record Key

688fbd92-93c7-44b7-866f-daac4f853114

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

May 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-