Catalog Number

-

Brand Name

COLORADO 2™ Spinal System

Version/Model Number

8632760

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 08, 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

K991031

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Public Device Record Key

1c7a6ab5-7757-4eec-9da2-88932414d0c6

Public Version Date

October 29, 2018

Public Version Number

4

DI Record Publish Date

August 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-