Catalog Number

-

Brand Name

DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM

Version/Model Number

77307478

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

-

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

K142450

Product Code

KWQ

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Public Device Record Key

722818d8-9f1a-4b01-bf4b-9f15aea95b1a

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

August 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-