Catalog Number

15-2230/10

Brand Name

Unicondylar Sled Prosthesis

Version/Model Number

15-2230/10

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

K152431,K212742

Product Code

HSX

Product Code Name

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

Public Device Record Key

68df3e60-24d9-4e40-b10d-fd86fc3e7bcc

Public Version Date

September 27, 2021

Public Version Number

4

DI Record Publish Date

May 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-