Catalog Number

6537.50.316

Brand Name

PHYSICA LMC

Version/Model Number

6537.50.316

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

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

K193284

Product Code

HRY

Product Code Name

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

Public Device Record Key

8a142895-c616-4bf0-83ec-571d9aa9d23a

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-