Catalog Number

-

Brand Name

DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM

Version/Model Number

77305456

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 2022

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

ea787a90-6456-42bc-b5bb-3db91940da12

Public Version Date

September 27, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-