Catalog Number

161-0021

Brand Name

Navigation

Version/Model Number

16-07-055

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K180796

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

49cb11fa-184b-4763-be93-8a454234b4d5

Public Version Date

September 28, 2018

Public Version Number

1

DI Record Publish Date

August 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-