XT001204-1

GUDID 00885556920640

4.5mm Proximal Tibia Plate 4 Hole EVOS

Smith & Nephew, Inc.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00885556920640
• NIH Device Record Key: 3446b91e-2252-4d0a-97ee-1bb510008200
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: XT001204-1
• Catalog Number: XT001204-1
• Company DUNS: 045483575
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556920640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993106

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556920640]

Moist Heat or Steam Sterilization

[00885556920640]

Moist Heat or Steam Sterilization

[00885556920640]

Moist Heat or Steam Sterilization

[00885556920640]

Moist Heat or Steam Sterilization

[00885556920640]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-10-28

Devices Manufactured by Smith & Nephew, Inc.

• 00885556000908 - Legion: 2024-11-05 1 Degree Varus/Valgus Recut Block
• 00885556000915 - Legion: 2024-11-05 2 Degree Varus/Valgus Recut Block
• 00885556920640 - NA: 2024-11-054.5mm Proximal Tibia Plate 4 Hole EVOS
• 00885556920640 - NA: 2024-11-05 4.5mm Proximal Tibia Plate 4 Hole EVOS
• 00885556920831 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 3-4 - 18mm
• 00885556920848 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 5-6 - 12mm
• 00885556920855 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 5-6 - 13mm
• 00885556920862 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 5-6 - 15mm
• 00885556920879 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 5-6 - 18mm