72720535

GUDID 00885556896495

TRIGEN MAX 5.0MM LAG SCREW - 35MM

Smith & Nephew, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00885556896495
• NIH Device Record Key: 0bbbf002-02ce-4901-a7f4-96f5656685c0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 72720535
• Catalog Number: 72720535
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556896495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240061

FDA Product Code

• HWC: Screw, fixation, bone

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: 2025-05-13
• Device Publish Date: 2025-05-05

Devices Manufactured by Smith & Nephew, Inc.

• 00885556896495 - NA: 2025-05-13TRIGEN MAX 5.0MM LAG SCREW - 35MM
• 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