HSX E0015411-4

GUDID 00885556689776

ZUK TIBIAL SIZING TEMPLATE SZ 4

Smith & Nephew, Inc.

Surgical implant template, reusable

• Primary Device ID: 00885556689776
• NIH Device Record Key: 1104f270-f85f-4d13-ae34-fe478c8155ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HSX
• Version Model Number: E0015411-4
• Catalog Number: E0015411-4
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556689776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113038

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

[00885556689776]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2017-04-17

Devices Manufactured by Smith & Nephew, Inc.

• 00885556921715 - LEGION: 2025-04-18 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 5-6 12MM
• 00885556922569 - LEGION: 2025-04-18 LEGION MEDIAL STABILIZED TRIAL INSERT W/JRNY LCK LEFT SZ 7-8 12MM
• 00885556922194 - LEGION: 2025-04-15 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK LEFT SZ 1-2 9MM
• 00885556922217 - LEGION: 2025-04-15 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK LEFT SZ 1-2 10MM
• 00885556905470 - NA: 2025-03-12 VARIABLE ANGLE VALGUS GUIDE
• 00885556880876 - EVOS: 2025-02-28 EVOS 2.7MM STAGGERED PATELLA PLATE
• 00885556880883 - EVOS: 2025-02-28 EVOS 2.7MM SPLIT PATELLA PLATE
• 00885556886403 - EVOS: 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - SMALL