Catalog Number

2N1AC20005

Brand Name

Shoulder Innovations TSA

Version/Model Number

20 mm x 5°

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 05, 2021

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

6c67c030-68cf-4b5d-8f59-18147f4b1565

Public Version Date

October 28, 2021

Public Version Number

3

DI Record Publish Date

May 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-