Titan™ STEM-0950-025-10165

GUDID 10381780364160

Total Shoulder System Cemented Long Stem, 10 x 165mm

Ascension Orthopedics, Inc.

Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis
Primary Device ID10381780364160
NIH Device Record Keyc0ccb473-e943-4fe5-9ec8-a1feb5d409b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitan™
Version Model NumberS95002510165
Catalog NumberSTEM-0950-025-10165
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

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]
GS110381780364160 [Primary]

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 Number2
Public Version Date2020-06-23
Device Publish Date2018-09-06

On-Brand Devices [Titan™]

10381780471288RSS Glenosphere Removal Handle-S
10381780459118RSS Reamer Guide Body Inserter/Extractor
10381780459101RSS Humeral Body Inserter/Extractor
M269SEP09200680011Titan™ Total Shoulder System The body separator is used in the removal of the proximal humeral
M269INS0960049011Titan™ Reverse Shoulder System The reamer guide body inserter/extractor is used to assist with
M269IS09500450011The humeral implant inserter/extractor is used to insert the implant into its place, as well as
M269INS0960048021The humeral body inserter/extractor knob is used to tighten or loosen the inserter/extractor.
M269INS0960048011The humeral body inserter/extractor is used to insert the implant into its place, as well as ext
M269HDL0960065011The glenosphere inserter is used to insert the glenosphere into the baseplate.
M269SET188A0011The head extractor is used to remove the humeral head.
M269INS09500460011The humeral trial inserter/extractor is used to insert the trial implant into its place, as well
M269INS09230460011The humeral trial inserter/extractor is used to insert the trial implant into its place, as well
M269INS09230450011The humeral implant inserter/extractor is used to insert the implant into its place, as well as
M269INS09200460011The humeral trial inserter/extractor is used to insert the trial implant into its place, as well
M269INS09200450011The humeral implant inserter/extractor is used to insert the implant into its place, as well as
M269GLN092603003A1The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
M269GLN092603002A1The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
M269GLN092603001A1The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
M269GLN092603000A1The Fin-Lock Glenoid implant is part of the Titan Modular Shoulder System. It is an anchor peg t
10381780467601RSS HXL Liner Retentive, +9R
10381780467595RSS HXL Liner Retentive, +6R
10381780467588RSS HXL Liner Retentive, +3R
10381780467571RSS HXL Liner Retentive, +0R
10381780467564RSS HXL Liner Standard, +9S
10381780467557RSS HXL Liner Standard, +6S
10381780467540RSS HXL Liner Standard, +3S
10381780467533RSS HXL Liner Standard, +0S
M269IMS0960070011Titan™ Reverse Shoulder System The stand is used as a base during stem impaction.
M269SCR0960062011Titan™ Reverse Shoulder System The 2.5 Hex Driver is used to tighten 4.5mm screws.
10381780467779RSS Double Drill Guide-S
10381780467762RSS Baseplate Boss Drill Guide-S
M269DRS09260011The Glenoid Drill Shaft is used to create holes.
M269DRL0926018S1Fin-Lock Central Drill
M269DRL0926018C1Fin-Lock Cannulated Central Drill
M269DRL0926015S1Fin-Lock Central Drill
M269DRL0926015C1Fin-Lock Cannulated Central Drill
M269DRL09260021Fin-Lock Peripheral Drill  
M269DRL09260011Fin-Lock Starter Drill  
M269DRG09260031Fin-Lock Starter Drill Guide
M269DRG09260021Fin-Lock Starter Drill Guide
M269DRG09260011The Fin-Lock Drill Guide is used for precision and accuracy when drilling.
M269STD09200710011Titan™ Total Shoulder System The stand is used as a base during head impaction.
M269SIS09200540011Titan™ Total Shoulder System The stand is used as a base during stem impaction.
M269INS0920071STD1Titan™ Total Shoulder System The stand insert is used as a base during head impaction.
M269INS0920071SML1Titan™ Total Shoulder System The stand insert is used as a base during head impaction.
M269INS0920071LRG1Titan™ Total Shoulder System The stand insert is used as a base during head impaction.
M269DRG0922067021Titan™ Total Shoulder System The glenoid drill guide is used for precision and accuracy when d
M269DRG0922067011Titan™ Total Shoulder System The glenoid drill guide is used for precision and accuracy when d
M269DRG09200490021Titan™ Total Shoulder System The center glenoid drill guide is used for precision and accuracy
M269DRG09200490011Titan™ Total Shoulder System The center glenoid drill guide is used for precision and accuracy

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