Titan™ Total Shoulder System BOD-0923-020-14STD

GUDID M269BOD092302014STD1

The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is designed to accommodate the natural humeral geometry, while providing stable fixation, proximal bone loading and proper head placement.

Ascension Orthopedics, Inc.

Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis Shoulder humeral body prosthesis
Primary Device IDM269BOD092302014STD1
NIH Device Record Key8169670f-6362-4d18-b210-086fd0ed6f03
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitan™ Total Shoulder System
Version Model NumberBOD-0923-020-14STD
Catalog NumberBOD-0923-020-14STD
Company DUNS942377524
Company NameAscension Orthopedics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
GS110381780123224 [Primary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]
HIBCCM269BOD092302014STD1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-23
Device Publish Date2017-10-09

On-Brand Devices [Titan™ Total Shoulder System]

10381780120223The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
M269GLN092003003K1The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
10381780120209The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
M269GLN092003002K1The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
M269GLN092003001P1The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal b
M269GLN092003001K1The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
M269GLN092003000P1The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal
M269GLN092003000K1The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal b
10381780422716TSS Modified Retractor Base
10381780364818TSS PIN BUSHING, 2.5 M-L
M269MHH09230105220E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230105220C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230105022E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230105022C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230105019E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230105019C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104821E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104821C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104818E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104818C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104815E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104815C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104620E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104620C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104617E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104617C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104614E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104614C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104419E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104419C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104416E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104416C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104216E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230104216C1The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral
M269MHH09230104015E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269MHH09230103814E1The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral
M269BOD092302108STD1The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
M269BOD092302108SML1The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
M269BOD092302108LRG1The Titan Modular Total Shoulder fracture body is shaped to provide proximal fixation and is des
M269BOD092302014STD1The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
M269BOD092302014SML1The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
M269BOD092302014LRG1The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
M269BOD092302012STD1The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
M269BOD092302010STD1The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
M269BOD092302010SML1The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
10381780123163The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
M269BOD092302008STD1The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
10381780123149The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
10381780123132The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi
10381780123125The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is desi

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