Titan Reverse Shoulder System SCW096005535

GUDID 00885556864371

5.5MM SCREW 35MM

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00885556864371
• NIH Device Record Key: 1e8c4b35-da7b-400e-8b41-784e74f4bb11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Reverse Shoulder System
• Version Model Number: SCW-0960-055-35
• Catalog Number: SCW096005535
• 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556864371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130050

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• PHX: shoulder prosthesis, reverse configuration

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: 2023-06-16

On-Brand Devices [Titan Reverse Shoulder System]

• 00885556864401: RSS 4.5MM STAR SCREW AND CAP 15MM LENGTH
• 00885556864487: RSS 4.5MM STAR SCREW AND CAP 55MM LENGTH
• 00885556864470: RSS 4.5MM STAR SCREW AND CAP 50MM LENGTH
• 00885556864463: RSS 4.5MM STAR SCREW AND CAP 45MM LENGTH
• 00885556864456: RSS 4.5MM STAR SCREW AND CAP 40MM LENGTH
• 00885556864449: RSS 4.5MM STAR SCREW AND CAP 35MM LENGTH
• 00885556864432: RSS 4.5MM STAR SCREW AND CAP 30MM LENGTH
• 00885556864104: RSS HXL LINER STANDARD. +0S
• 00885556863725: REVERSE BASEPLATE 15MM
• 00885556864814: RSS GLENOSPHERE TRIAL. ECCENTRIC-S
• 00885556864807: RSS GLENOSPHERE TRIAL. CONCENTRIC-S
• 00885556864791: RSS GLENOSPHERE TRIAL. ECCENTRIC-S
• 00885556864784: RSS GLENOSPHERE TRIAL. CONCENTRIC-S
• 00885556864616: RSS HEAD CUTTING TEMPLATE 142.5DEG. RIGHT
• 00885556864609: RSS HEAD CUTTING TEMPLATE 142.5DEG. LEFT
• 00885556864593: RSS HEAD CUTTING TEMPLATE 142.5 RIGHT
• 00885556864586: RSS HEAD CUTTING TEMPLATE 142.5 LEFT
• 00885556864333: T-15 STAR DRIVER FOR 4.5MM SCREWS
• 00885556864326: HEX DRIVER FOR 4.5MM SCREWS
• 00885556864289: RSS BASEPLATE PERIPHERAL REAMER. CONCENTRIC-S
• 00885556864272: RSS BASEPLATE PERIPHERAL REAMER. ECCENTRIC-S
• 00885556864265: PERIPHERAL REAMER ECCENTRIC MOD
• 00885556864258: PERIPHERAL REAMER CONCENTRIC MOD
• 00885556864241: HUMERAL REAMER MOD
• 00885556864203: RSS 4.5MM DEPTH GAGE
• 00885556864012: RSS REAMER GUIDE BODY INSERTER / EXTRACTOR
• 00885556864005: RSS HUMERAL BODY INSERTER / EXTRACTOR
• 00885556863978: REAMER GUIDE BODY INSERTER/ EXTRACTOR MOD
• 00885556863961: HUMERAL BODY INSERTER/EXTRACTOR
• 00885556863954: STEM IMPACTION STAND MOD
• 00885556863930: LINER IMPACTOR MOD
• 00885556863923: GLENOSPHERE IMPACTOR MOD
• 00885556863916: GLENOID BASEPLATE IMPACTOR MOD
• 00885556863909: RSS IM CUT BLOCK
• 00885556863893: RSS GLENOSPHERE REMOVAL HANDLE-S
• 00885556863886: RSS GLENOSPHERE REMOVAL HANDLE
• 00885556863879: RSS GLENOSPHERE INSERTER
• 00885556863855: RSS GLENOID BASEPLATE WIRE GUIDE
• 00885556863848: ECCENTRIC WIRE GUIDE WITH LIP
• 00885556863831: CONCENTRIC WIRE GUIDE WITH LIP
• 00885556863718: HUMERAL BODY TRIAL W/ DEFINITIVE STD MOD
• 00885556863701: HUMERAL BODY TRIAL W/ DEFINITIVE SML MOD
• 00885556863695: HUMERAL BODY TRIAL W/ DEFINITIVE LRG MOD
• 00885556863596: DEPTH STOP MOD
• 00885556863589: RSS DOUBLE DRILL GUIDE-S
• 00885556863565: INSTRUMENT TRAY INSERT ASSEMBLY
• 00885556863558: INSTRUMENT TRAY BASE ASSEMBLY
• 00885556863541: REVERSE INSTRUMENT CASE INSERT
• 00885556863534: REVERSE INSTRUMENT CASE BASE
• 00885556863503: RSS BASEPLATE BOSS DRILL GUIDE-S