Catalog Number

-

Brand Name

Tibial cutting block

Version/Model Number

42160370

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HSX

Product Code Name

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

Public Device Record Key

e94c03ee-ed4f-43eb-9046-af7ebad857cf

Public Version Date

September 10, 2021

Public Version Number

1

DI Record Publish Date

September 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-