Catalog Number

110026855

Brand Name

G7® Acetabular System

Version/Model Number

110026855

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

K150522

Product Code

KWY

Product Code Name

Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Public Device Record Key

2a8f4b4c-11f7-44c0-bff9-c588170aae30

Public Version Date

December 01, 2021

Public Version Number

1

DI Record Publish Date

November 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-