KLEGION 71425525

GUDID 00885556790687

LEGION CR STD INSERT W/ JRNY LOCK SZ 7-8 18MM

Smith & Nephew, Inc.

Tibial insert

• Primary Device ID: 00885556790687
• NIH Device Record Key: 81df8687-f997-4221-b211-df7f5fa5e844
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KLEGION
• Version Model Number: 71425525
• Catalog Number: 71425525
• 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)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	00885556790687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220896

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-07
• Device Publish Date: 2022-06-29

Devices Manufactured by Smith & Nephew, Inc.

• 00885556892596 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 34CM LEFT
• 00885556892619 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 36CM LEFT
• 00885556892626 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 37CM LEFT
• 00885556892633 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 38CM LEFT
• 00885556892640 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 39CM LEFT
• 00885556892657 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 40CM LEFT
• 00885556892664 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 41CM LEFT
• 00885556892671 - TRIGEN MAX: 2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 42CM LEFT