Catalog Number

70-SC-0100

Brand Name

Navigated Instrument System

Version/Model Number

70-SC-0100

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

K181606

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

d593c885-1be3-488b-8a58-39acbffc6d89

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-