Titan™ Reverse Shoulder System GLS-0960-02E

GUDID M269GLS096002E1

Eccentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft tissue tensioning, maximize stability, increase range of motion and minimize scapular notching.

Ascension Orthopedics, Inc.

Reverse shoulder prosthesis head

• Primary Device ID: M269GLS096002E1
• NIH Device Record Key: 0f5e6f77-9b09-4fde-8374-83bcd94d6f84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan™ Reverse Shoulder System
• Version Model Number: GLS096002E
• Catalog Number: GLS-0960-02E
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780121657 [Primary]
HIBCC	M269GLS096002E1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130050

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-06
• Device Publish Date: 2017-10-09

On-Brand Devices [Titan™ Reverse Shoulder System]

• 10381780441120: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121831: Central Compression Screw is a large Independent compression screw used in the Titan™ Reverse
• 10381780121824: Central Compression Screw is a large Independent compression screw used in the Titan™ Reverse
• 10381780121817: Central Compression Screw is a large Independent compression screw used in the Titan™ Reverse
• 10381780121800: Central Compression Screw is a large Independent compression screw used in the Titan™ Reverse
• 10381780121794: Central Compression Screw is a large Independent compression screw used in the Titan™ Reverse
• 10381780121787: Central Compression Screw is a large Independent compression screw used in the Titan™ Reverse
• 10381780121770: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121763: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121756: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121749: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121732: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121725: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121718: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121701: Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps
• 10381780121695: The Titan Reverse Shoulder baseplate is a glenoid component secured by four peripheral screws, t
• 10381780121688: The Titan Reverse Shoulder baseplate is a glenoid component secured by four peripheral screws, t
• 10381780121671: Eccentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft
• M269GLS096005E1: Eccentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft
• M269GLS096002E1: Eccentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft
• M269GLS096005C1: Concentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft
• M269GLS096002C1: Concentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft
• 10381780121626: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• 10381780121619: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• M269LNR096003S1: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• M269LNR096000S1: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• 10381780121589: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• 10381780121572: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• M269LNR096003R1: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• M269LNR096000R1: The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumer
• M269BBS096021LRG1: The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increa
• M269BBS096021STD1: The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increa
• 10381780121527: The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increa