Titan Modular Shoulder System STEM-0950-02510125

GUDID 00885556837672

CEMENTED LONG STEM. 10MMX125MM

Smith & Nephew, Inc.

Uncoated shoulder humeral stem prosthesis

• Primary Device ID: 00885556837672
• NIH Device Record Key: 1719af92-f0f7-4bdb-a2eb-ea55b83d9621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Modular Shoulder System
• Version Model Number: STEM-0950-025-10125
• Catalog Number: STEM-0950-02510125
• 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	00885556837672 [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