Catalog Number

80-2511

Brand Name

FacetLINK MI

Version/Model Number

80-2511

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

-

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

K123497

Product Code

MRW

Product Code Name

System, Facet Screw Spinal Device

Public Device Record Key

d6a67746-7bbf-4bc0-999c-2ca420efe135

Public Version Date

November 27, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-