71931291

GUDID 00885556054444

SUPER HIGH OFFSET PC STEM SZ 11

Smith & Nephew, Inc.

Coated hip femur prosthesis, modular

• Primary Device ID: 00885556054444
• NIH Device Record Key: eed7266f-fb6e-41ab-8c35-a6696f609aa4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71931291
• Catalog Number: 71931291
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556054444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963509

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

• 00885556903421 - EVOS: 2025-09-10 EVOS PELVIC 5.0MM X 135MM CANNULATED SCREW FULLY THREADED
• 00885556903438 - EVOS: 2025-09-08 EVOS PELVIC 5.0MM X 140MM CANNULATED SCREW FULLY THREADED
• 00885556903445 - EVOS: 2025-09-08 EVOS PELVIC 5.0MM X 145MM CANNULATED SCREW FULLY THREADED
• 00885556903452 - EVOS: 2025-09-08 EVOS PELVIC 5.0MM X 150MM CANNULATED SCREW FULLY THREADED
• 00885556903469 - EVOS: 2025-09-08 EVOS PELVIC 5.0MM X 50MM CANNULATED SCREW PARTIALLY THREADED 32MM
• 00885556903476 - EVOS: 2025-09-08 EVOS PELVIC 5.0MM X 55MM CANNULATED SCREW PARTIALLY THREADED 32MM
• 00885556903483 - EVOS: 2025-09-08 EVOS PELVIC 5.0MM X 60MM CANNULATED SCREW PARTIALLY THREADED 32MM
• 00885556903490 - EVOS: 2025-09-08 EVOS PELVIC 5.0MM X 65MM CANNULATED SCREW PARTIALLY THREADED 32MM