Titan™ Total Shoulder System - The Titan Modular Total Shoulder Humeral Head has - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The h The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing.

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More Product Details

Catalog Number

MHH-0923-010-4818C

Brand Name

Titan™ Total Shoulder System

Version/Model Number

MHH-0923-010-4818C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K142413

Product Code Details

Product Code

HSD

Product Code Name

PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Device Record Status

Public Device Record Key

57cc0301-01d9-4bbf-9563-418c60737c44

Public Version Date

June 23, 2020

Public Version Number

4

DI Record Publish Date

October 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCENSION ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1909
2 A medical device with a moderate to high risk that requires special controls. 1404
3 A medical device with high risk that requires premarket approval 12
U Unclassified 15