Titan Modular Shoulder System 2.5 STEM-0920-025-13

GUDID 00885556862117

TSS PRESS FIT STEM SZ. 13

Smith & Nephew, Inc.

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00885556862117
• NIH Device Record Key: 647f13f4-1218-479a-a739-262b54ab296c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Modular Shoulder System 2.5
• Version Model Number: STEM-0920-025-13
• Catalog Number: STEM-0920-025-13
• 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	00885556862117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100448

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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: 2022-12-21

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