Catalog Number

161-0033

Brand Name

Spineology Navigation Instruments

Version/Model Number

16-08-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K182345

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

a66fe45f-2a0c-45a6-ad94-f034ac1b3b06

Public Version Date

May 03, 2019

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-