Catalog Number

-

Brand Name

SI-LOK

Version/Model Number

6202.6652

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

K183119

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

0921eed2-b259-43ff-b6ef-82603a387997

Public Version Date

March 16, 2020

Public Version Number

1

DI Record Publish Date

March 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-