Catalog Number

RQI00016

Brand Name

CoFix Implant 16 mm

Version/Model Number

RQI00016

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

K153302

Product Code

PEK

Product Code Name

Spinous Process Plate

Public Device Record Key

fa1c3b0e-ebd5-4e3e-961c-8454af871292

Public Version Date

June 10, 2021

Public Version Number

3

DI Record Publish Date

March 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-