74033675

GUDID 03596010671837

UNIVERSAL INSERT SPACER SIZE 7-8 15MM

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 03596010671837
• NIH Device Record Key: c2976679-0a56-4534-9f09-4d4afb517a59
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 74033675
• Catalog Number: 74033675
• 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)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	03596010671837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111711

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

[03596010671837]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-10-11
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

• 00885556896495 - NA: 2025-05-13 TRIGEN MAX 5.0MM LAG SCREW - 35MM
• 00885556896501 - NA: 2025-05-13 TRIGEN MAX 5.0MM LAG SCREW - 37.5MM
• 00885556896518 - NA: 2025-05-13 TRIGEN MAX 5.0MM LAG SCREW - 40MM
• 00885556896525 - NA: 2025-05-13 TRIGEN MAX 5.0MM LAG SCREW - 42.5MM
• 00885556898994 - NA: 2025-05-13 TRIGEN MAX 20MM SPIKED WASHER
• 00885556921562 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 11MM
• 00885556921579 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 12MM
• 00885556921586 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 13MM