Catalog Number

421833

Brand Name

Hintermann Series H2

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171004

Product Code

HSN

Product Code Name

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Public Device Record Key

4a8c8046-2ca0-4179-9ff3-92e42876cdc9

Public Version Date

October 16, 2020

Public Version Number

4

DI Record Publish Date

March 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-