Catalog Number

P09251000

Brand Name

Onyx PLIF PEEK

Version/Model Number

P09251000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

K110659

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

83b5e37c-f763-4fbc-88ce-67a0e1d2675f

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

April 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-