Catalog Number

FOGS-0012/1

Brand Name

FO Micro Screw System

Version/Model Number

FOGS-0012

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

K180348

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

c565825c-002c-4469-a9a6-b98f17d69175

Public Version Date

April 06, 2020

Public Version Number

2

DI Record Publish Date

January 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-