Shoulder Innovations Humeral Short Stem System - Shoulder Innovations - TSA - Humeral Short Stem - Shoulder Innovations, Inc.

Duns Number:080404519

Device Description: Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 56mm D Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 56mm Diameter R33mm Articulation.

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More Product Details

Catalog Number

2N12HE18056

Brand Name

Shoulder Innovations Humeral Short Stem System

Version/Model Number

18mm x 56mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K173824,K102670,K110905,K111596

Product Code Details

Product Code

HSD

Product Code Name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Device Record Status

Public Device Record Key

c7bc1eef-a47c-4c75-8d9d-4f0051ad466d

Public Version Date

August 10, 2021

Public Version Number

3

DI Record Publish Date

December 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHOULDER INNOVATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 443