Bone Screws 180-458/25

GUDID 04026575273676

Bone Screw, uncemented, Ti6Al4V, fixation of metal casing

WALDEMAR LINK GmbH & Co. KG

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 04026575273676
• NIH Device Record Key: cacaf285-7aa4-4a8e-9479-f2f0cc721e19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Screws
• Version Model Number: 180-458/25
• Catalog Number: 180-458/25
• 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	04026575273676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241636

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [Bone Screws]

• 04026575273744: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273737: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273720: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273713: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273706: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273690: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273683: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273676: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575273669: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing
• 04026575182510: Bone Screw, uncemented, Ti6Al4V, fixation of metal casing