TrabecuLink Augments 185-046/15

GUDID 04026575267460

Acetabular augment, Ti6Al4V - 3D-printed

WALDEMAR LINK GmbH & Co. KG

Acetabular augmentation implant

• Primary Device ID: 04026575267460
• NIH Device Record Key: 8a255a78-ca9b-421b-bf05-65e5d2b7f301
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrabecuLink Augments
• Version Model Number: 185-046/15
• Catalog Number: 185-046/15
• 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	04026575267460 [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: 2025-01-21
• Device Publish Date: 2025-01-13

On-Brand Devices [TrabecuLink Augments]

• 04026575267699: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267682: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267675: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267668: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267651: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267644: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267637: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267620: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267613: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267606: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267590: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267583: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267576: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267569: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267552: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267545: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267521: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267514: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267507: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267491: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267484: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267477: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267460: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267453: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267446: Acetabular augment, Ti6Al4V - 3D-printed
• 04026575267439: Acetabular augment, Ti6Al4V - 3D-printed