Catalog Number

-

Brand Name

coflex Interlaminar Technology, 8mm

Version/Model Number

UQI00008

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

P110008

Product Code

NQO

Product Code Name

Prosthesis, Spinous Process Spacer/Plate

Public Device Record Key

20db9606-be51-447b-ae4c-1f6d542afe7c

Public Version Date

June 10, 2021

Public Version Number

5

DI Record Publish Date

July 28, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-