Catalog Number

9065.1U.110

Brand Name

Physica system

Version/Model Number

9065.1U.110

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

K141934

Product Code

HRY

Product Code Name

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Public Device Record Key

06595e9d-bedf-4a80-9589-6eb81868e972

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-