Titan Modular Shoulder System STEM-0950-02512125

GUDID 00885556837696

CEMENTED LONG STEM. 12MMX125MM

Smith & Nephew, 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 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 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 Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis

• Primary Device ID: 00885556837696
• NIH Device Record Key: eb0fbbc4-2e44-4a40-b37a-213f81f94a6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Modular Shoulder System
• Version Model Number: STEM-0950-025-12125
• Catalog Number: STEM-0950-02512125
• 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
• 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	00885556837696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112438
• Premarket Notification: K142413

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-17

On-Brand Devices [Titan Modular Shoulder System]

• 00885556860779: TSS TRIAL INSERTER/EXTRACTOR. 2.5
• 00885556862964: GLENOID PEGGED TRIAL LARGEL
• 00885556862957: GLENOID KEELED TRIAL LARGE
• 00885556862940: GLENOID PEGGED TRIAL MEDIUM
• 00885556862933: GLENOID KEELED TRIAL MEDIUM
• 00885556862926: GLENOID PEGGED TRIAL SMALL
• 00885556862919: GLENOID KEELED TRIAL SMALL
• 00885556862902: GLENOID PEGGED TRIAL EXTRA SMALL
• 00885556862896: GLENOID KEELED TRIAL EXTRA SMALL
• 00885556862827: DEFINITIVE STEM PRIMARY BODY TRIAL 14STD
• 00885556862810: DEFINITIVE STEM PRIMARY BODY TRIAL 14SML
• 00885556862803: DEFINITIVE STEM PRIMARY BODY TRIAL 14LRG
• 00885556862797: DEFINITIVE STEM PRIMARY BODY TRIAL 12STD
• 00885556862780: DEFINITIVE STEM PRIMARY BODY TRIAL 10STD
• 00885556862773: DEFINITIVE STEM PRIMARY BODY TRIAL 10SML
• 00885556862766: DEFINITIVE STEM PRIMARY BODY TRIAL 10LRG
• 00885556862759: DEFINITIVE STEM PRIMARY BODY TRIAL 08STD
• 00885556862742: BODY TRIAL 14 STANDARD
• 00885556862735: BODY TRIAL 14 SMALL
• 00885556862728: BODY TRIAL 14 LARGE
• 00885556862711: BODY TRIAL 12 STANDARD
• 00885556862704: BODY TRIAL 10 STANDARD
• 00885556862698: BODY TRIAL 10 SMALL
• 00885556862681: BODY TRIAL 10 LARGE
• 00885556862674: BODY TRIAL 8 STANDARD
• 00885556862407: HEAD CUTTING TEMPLATE. RIGHT
• 00885556862391: HEAD CUTTING TEMPLATE. LEFT
• 00885556861554: FIXATION PIN
• 00885556861530: ANTI-ROTATION PEG
• 00885556860809: TSS HEAD IMPACTOR
• 00885556860618: HUMERAL DEPTH STOP
• 00885556860601: MINI GLENOID HOLDER
• 00885556860595: GLENOID HOLDER
• 00885556860526: ANTI-ROTATION PEG HOLDER
• 00885556860519: STEM TRIAL HANDLE
• 00885556860243: SLOTTED MALLET
• 00885556860151: TSS GLENOID SOLID PEG DRILL
• 00885556859995: TSS MODIFIED RETRACTOR BASE
• 00885556859254: TAPER ADAPTER
• 00885556859247: STARTER AWL 6MM
• 00885556859209: TRIAL ADAPTOR TSS
• 00885556837818: CEMENTED LONG STEM TRIAL SZ. 12X165
• 00885556837801: CEMENTED LONG STEM TRIAL SZ. 12X125
• 00885556837795: CEMENTED LONG STEM TRIAL SZ. 10X165
• 00885556837788: CEMENTED LONG STEM TRIAL SZ. 10X125
• 00885556837771: CEMENTED LONG STEM TRIAL SZ. 08X165
• 00885556837764: CEMENTED LONG STEM TRIAL SZ. 08X125
• 00885556837702: CEMENTED LONG STEM. 12MMX165MM
• 00885556837696: CEMENTED LONG STEM. 12MMX125MM
• 00885556837689: CEMENTED LONG STEM. 10MMX165MM