Catalog Number

-

Brand Name

Nexxt Spine Navigation System

Version/Model Number

I10NAV-13-01

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

K220291

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

4bbee427-36b8-491b-be08-096546e1f2b0

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-