75100840

GUDID 07611996121735

TRIAL FEMORAL HEAD 22 M/+4

Smith & Nephew, Inc.

Femoral head prosthesis trial

• Primary Device ID: 07611996121735
• NIH Device Record Key: f1392b44-6c9b-4a05-b070-711465dd8b7d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 75100840
• Catalog Number: 75100840
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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	07611996121735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132435

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

[07611996121735]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

• 00885556909393 - NA: 2025-10-02 Cup Impactor - Offset
• 00885556906941 - EVOS: 2025-10-01 EVOS PELVIC 3.5MM LOCKING CURVED RECON PLATE 10 HOLE
• 00885556907207 - EVOS: 2025-10-01 EVOS PELVIC 2.7MM SHORT SEGMENT CURVED UTILITY PLATE
• 00885556907214 - EVOS: 2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 2 HOLE
• 00885556907221 - EVOS: 2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 4 HOLE
• 00885556907245 - EVOS: 2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 6 HOLE
• 00885556907252 - EVOS: 2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 8 HOLE
• 00885556907290 - EVOS: 2025-10-01 EVOS PELVIC 2.7MM/3.5MM SYMPHYSIS LOCKING PLATE TABBED 4 HOLE