Titan™ Modular Total Shoulder System TITANH1IMP

GUDID M268TITANH1IMP1

The Titan Modular Total Shoulder System humeral set 2.5 consists of body trials and humeral stem trials. A locking body screw is included for implantation. Instruments are provided to facilitate the placement of the trials and screw. The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable.

Ascension Orthopedics, Inc.

Joint prosthesis implantation kit, reusable

• Primary Device ID: M268TITANH1IMP1
• NIH Device Record Key: b5da7b9a-9f45-4ab4-9495-afed8d6c0515
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Titan™ Modular Total Shoulder System
• Version Model Number: TITANH1IMP
• Catalog Number: TITANH1IMP
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780125693 [Primary]
HIBCC	M268TITANH1IMP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142413

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

[M268TITANH1IMP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• Device Publish Date: 2015-09-22

On-Brand Devices [Titan™ Modular Total Shoulder System]

• M268TSS1IMP1: The Titan Modular Total Shoulder System Humeral tray consists of body trials and humeral stem tr
• M268TITANH1IMP1: The Titan Modular Total Shoulder System humeral set 2.5 consists of body trials and humeral stem