Catalog Number

SurgiCase Knee Planner

Brand Name

SurgiCase Planner

Version/Model Number

SurgiCase Knee Planner

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173970,K173445,K172650,K162273,K150928

Product Code

HSX

Product Code Name

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

Public Device Record Key

316ef4d7-a42e-4e9c-8938-015bbb96f3ca

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

October 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-