Catalog Number

22-9221

Brand Name

INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE

Version/Model Number

22-9221

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122008

Product Code

OVE

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Cervical

Public Device Record Key

082b17d6-76b3-45bd-8835-0b86003e91b5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-