Link OptiStem

GUDID 04026575285518

Fixation screw, Ti6Al4V, for Link Endo-Model EVO -M, torque limiting

WALDEMAR LINK GmbH & Co. KG

Implantable orthopaedic/craniofacial device connection screw

• Primary Device ID: 04026575285518
• NIH Device Record Key: 4fbf076a-d257-4ba3-b71f-3da58dfe3a04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Link OptiStem
• Version Model Number: 17-1001/00
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575285518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220628

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-09
• Device Publish Date: 2023-01-26

On-Brand Devices [Link OptiStem]

• 04026575285518: Fixation screw, Ti6Al4V, for Link Endo-Model EVO -M, torque limiting
• 04026575284559: Fixation screw, Ti6Al4V, for Endo-Model SL / LINK Endo-Model EVO -W, torque limiting