Catalog Number

KNM-LM01-01-01

Brand Name

Lima PSI

Version/Model Number

KNM-LM01-01-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 2017

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

K162273

Product Code

JWH

Product Code Name

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

Public Device Record Key

0fe85e1e-3b9d-496a-8d04-6f99656fd9da

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-