Catalog Number

11291-1609

Brand Name

Nanovis Cervical FortiCore

Version/Model Number

11291-1609

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

-

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Public Device Record Key

6420d975-6104-4762-b6d2-db4321e097ce

Public Version Date

April 15, 2020

Public Version Number

1

DI Record Publish Date

April 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-