Catalog Number

2N1AI22010

Brand Name

Shoulder Innovations TSA

Version/Model Number

22 mm x 10°

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

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

K111596,K102670,K110905

Product Code

HSD

Product Code Name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Public Device Record Key

414059dd-6326-415a-ae31-2db6a4c75a26

Public Version Date

August 10, 2021

Public Version Number

3

DI Record Publish Date

November 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-