Titan™ Total Shoulder System MHH-0920-010-4815E

GUDID 10381780120384

The Titan Modular Total Shoulder Humeral Head has an eccentric 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.

Ascension Orthopedics, Inc.

Stem-fixed humeral head prosthesis

• Primary Device ID: 10381780120384
• NIH Device Record Key: a5523df6-e3a9-4cd3-975c-fde3831b74fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan™ Total Shoulder System
• Version Model Number: M9200104815E
• Catalog Number: MHH-0920-010-4815E
• 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
• 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 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	10381780120384 [Primary]
HIBCC	M268MHH09200104815E1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142413

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: 2020-06-23
• Device Publish Date: 2017-10-09

On-Brand Devices [Titan™ Total Shoulder System]

• 10381780120223: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
• M269GLN092003003K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• 10381780120209: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
• M269GLN092003002K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• M269GLN092003001P1: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
• M269GLN092003001K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• M269GLN092003000P1: The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal
• M269GLN092003000K1: The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
• 10381780422716: TSS Modified Retractor Base
• 10381780364818: TSS PIN BUSHING, 2.5 M-L
• M269MHH09230105220E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230105220C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230105022E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230105022C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230105019E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230105019C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104821E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104821C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104818E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104818C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104815E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104815C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104620E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104620C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104617E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104617C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104614E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104614C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104419E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104419C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104416E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104416C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104216E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230104216C1: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
• M269MHH09230104015E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269MHH09230103814E1: The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
• M269BOD092302108STD1: The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
• M269BOD092302108SML1: The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
• M269BOD092302108LRG1: The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
• M269BOD092302014STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302014SML1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302014LRG1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302012STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302010STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302010SML1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123163: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• M269BOD092302008STD1: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123149: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123132: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
• 10381780123125: The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi