Catalog Number

-

Brand Name

coflex-F trial with X-ray marker, Size 14

Version/Model Number

RDT00014

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

K093438

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

057fa74d-12b0-4947-84eb-a8ff3f6da62e

Public Version Date

June 10, 2021

Public Version Number

5

DI Record Publish Date

June 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-