Catalog Number

-

Brand Name

NAVIGATION INSTRUMENTS

Version/Model Number

6149.9145

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180690

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

c61db0ba-f64b-4191-bdd4-aaf9880df7d8

Public Version Date

September 04, 2018

Public Version Number

1

DI Record Publish Date

August 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-