Catalog Number

51-575-FX-35

Brand Name

QUANTUM™* MIS CANNULATED SYSTEM

Version/Model Number

51-575-FX-35

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 18, 2018

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

K101790

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Public Device Record Key

14c34263-1687-4b04-969e-ba529c34a7c9

Public Version Date

October 14, 2021

Public Version Number

5

DI Record Publish Date

November 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-