Catalog Number

-

Brand Name

PEEK PREVAIL™ Cervical Interbody Device

Version/Model Number

9010000036

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

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

K094042

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Public Device Record Key

9182ea75-c748-44bb-85bd-6a482ac19f94

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-