Catalog Number

CH121410

Brand Name

CxHA™

Version/Model Number

CH121410

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

K181115,K181115

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Public Device Record Key

0a3f77c9-ff0a-4618-b518-8800eb00d3ad

Public Version Date

October 31, 2018

Public Version Number

1

DI Record Publish Date

September 30, 2018

Package DI Number

M711CH1214101

Quantity per Package

1

Contains DI Package

M711CH1214100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton