Titan Modular Shoulder System 2.5 BOD-0923-020-14LRG

GUDID 00885556859445

TSS PRIMARY PROXIMAL BODY. 2.5 14LRG

Smith & Nephew, 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 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 Shoulder humeral body prosthesis

• Primary Device ID: 00885556859445
• NIH Device Record Key: 14e7ff3e-6230-49a0-9040-8d32d6ce9b0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Modular Shoulder System 2.5
• Version Model Number: BOD-0923-020-14LRG
• Catalog Number: BOD-0923-020-14LRG
• Company DUNS: 109903521
• Company Name: Smith & Nephew, 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556859445 [Primary]

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: 2
• Public Version Date: 2023-07-17
• Device Publish Date: 2022-12-22

On-Brand Devices [Titan Modular Shoulder System 2.5]

• 00885556863459: TAPER DISASSEMBLY TOOL
• 00885556863398: TSS DEFINITIVE STEM FRACTURE BODY TRIAL STD. 2.5
• 00885556863381: TSS DEFINITIVE STEM FRACTURE BODY TRIAL SML. 2.5
• 00885556863374: TSS DEFINITIVE STEM FRACTURE BODY TRIAL LRG. 2.5
• 00885556863367: TSS FRACTURE BODY TRIAL STD. 2.5
• 00885556863350: TSS FRACTURE BODY TRIAL SML. 2.5
• 00885556863343: TSS FRACTURE BODY TRIAL LRG. 2.5
• 00885556863336: TSS HEAD TRIAL ECCENTRIC. 2.5 52X20MM
• 00885556863329: TSS HEAD TRIAL CONCENTRIC. 2.5 52X20MM
• 00885556863312: TSS HEAD TRIAL ECCENTRIC. 2.5 50X22MM
• 00885556863305: TSS HEAD TRIAL CONCENTRIC. 2.5 50X22MM
• 00885556863299: TSS HEAD TRIAL ECCENTRIC. 2.5 50X19MM
• 00885556863282: TSS HEAD TRIAL CONCENTRIC. 2.5 50X19MM
• 00885556863275: TSS HEAD TRIAL ECCENTRIC. 2.5 48X21MM
• 00885556863268: TSS HEAD TRIAL CONCENTRIC. 2.5 48X21MM
• 00885556863251: TSS HEAD TRIAL ECCENTRIC. 2.5 48X18MM
• 00885556863244: TSS HEAD TRIAL CONCENTRIC. 2.5 48X18MM
• 00885556863237: TSS HEAD TRIAL ECCENTRIC. 2.5 48X15MM
• 00885556863220: TSS HEAD TRIAL CONCENTRIC. 2.5 48X15MM
• 00885556863213: TSS HEAD TRIAL ECCENTRIC. 2.5 46X20MM
• 00885556863206: TSS HEAD TRIAL CONCENTRIC. 2.5 46X20MM
• 00885556863190: TSS HEAD TRIAL ECCENTRIC. 2.5 46X17MM
• 00885556863183: TSS HEAD TRIAL CONCENTRIC. 2.5 46X17MM
• 00885556863176: TSS HEAD TRIAL ECCENTRIC. 2.5 46X14MM
• 00885556863169: TSS HEAD TRIAL CONCENTRIC. 2.5 46X14MM
• 00885556863152: TSS HEAD TRIAL ECCENTRIC. 2.5 44X19MM
• 00885556863145: TSS HEAD TRIAL CONCENTRIC. 2.5 44X19MM
• 00885556863138: TSS HEAD TRIAL ECCENTRIC. 2.5 44X16MM
• 00885556863121: TSS HEAD TRIAL CONCENTRIC. 2.5 44X16MM
• 00885556863114: TSS HEAD TRIAL ECCENTRIC. 2.5 42X16MM
• 00885556863107: TSS HEAD TRIAL CONCENTRIC. 2.5 42X16MM
• 00885556863091: TSS HEAD TRIAL ECCENTRIC. 2.5 40X15MM
• 00885556863084: TSS HEAD TRIAL ECCENTRIC. 2.5 38X14MM
• 00885556862261: TSS STEM IMPACTION STAND
• 00885556862254: TAPER ADAPTER SHAFT
• 00885556862193: BODY SEPARATOR
• 00885556862162: HEAD CUTTING GUIDE
• 00885556862155: HEAD EXTRACTOR
• 00885556862032: HEAD IMPACTION STAND. BASE ASSEMBLY
• 00885556861912: TSS HEAD CUTTING TEMPLATE ROD. 2.5
• 00885556861745: TSS TRIAL CALCAR PLANER. 2.5
• 00885556861608: FIN-LOCK PUNCH
• 00885556861592: GLENOID PEGGED PUNCH MED/LG
• 00885556861585: GLENOID PEGGED PUNCH XSM/SM
• 00885556861578: GLENOID KEELED PUNCH MED/LG
• 00885556861561: GLENOID KEELED PUNCH XSM/SM
• 00885556861516: MONOBLOCK HUMERAL SOUNDER. 16 MM
• 00885556861509: MONOBLOCK HUMERAL SOUNDER. 15 MM
• 00885556861493: MONOBLOCK HUMERAL SOUNDER. 14 MM
• 00885556861486: MONOBLOCK HUMERAL SOUNDER. 13 MM