Titan™ Reverse Shoulder System BBS-0960-21LRG

GUDID M269BBS096021LRG1

The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.

Ascension Orthopedics, Inc.

Reverse shoulder prosthesis body

• Primary Device ID: M269BBS096021LRG1
• NIH Device Record Key: d24369d7-68c3-42b5-ac98-9a44c7e25c2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan™ Reverse Shoulder System
• Version Model Number: BBS096021LRG
• Catalog Number: BBS-0960-21LRG
• 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	10381780121541 [Primary]
HIBCC	M269BBS096021LRG1 [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