Catalog Number

80-1011/35

Brand Name

FacetLink System

Version/Model Number

80-1011/35

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K123497

Product Code

MRW

Product Code Name

System, Facet Screw Spinal Device

Public Device Record Key

e23dcb9e-36ca-4043-9f34-8216f3063a6e

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

November 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-