Catalog Number

-

Brand Name

GEO Bone Screw System

Version/Model Number

10002010

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

Yes

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

K161904

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

ed39363d-607f-4896-94ed-c0a84f382bd7

Public Version Date

November 12, 2018

Public Version Number

1

DI Record Publish Date

October 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-