Catalog Number

PD-31-203

Brand Name

CAVUX Cervical Cage-X

Version/Model Number

PD-31-203

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

K122801,K122801

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Public Device Record Key

4c9f7ed8-aff3-41eb-9c6b-ea0b7af53cc8

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 12, 2020

Package DI Number

10852776006499

Quantity per Package

1

Contains DI Package

00852776006492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box