Intramedullary Plugs

GUDID 04026575230877

Intramedullary Plug, Ø12 mm

WALDEMAR LINK GmbH & Co. KG

Polymer orthopaedic cement restrictor, non-bioabsorbable

• Primary Device ID: 04026575230877
• NIH Device Record Key: 76f08f35-2e5f-4e67-8241-ef6db05ff68f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intramedullary Plugs
• Version Model Number: 109-130/12
• 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	04026575230877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250375

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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: 2025-12-02
• Device Publish Date: 2025-11-24

On-Brand Devices [Intramedullary Plugs]

• 04026575266036: Intramedullary Plug, Ø11 mm
• 04026575266029: Intramedullary Plug, Ø10 mm
• 04026575266012: Intramedullary Plug, Ø9 mm
• 04026575266005: Intramedullary Plug, Ø8 mm
• 04026575230952: Intramedullary Plug, Ø20 mm
• 04026575230945: Intramedullary Plug, Ø19 mm
• 04026575230938: Intramedullary Plug, Ø18 mm
• 04026575230921: Intramedullary Plug, Ø17 mm
• 04026575230914: Intramedullary Plug, Ø16 mm
• 04026575230907: Intramedullary Plug, Ø15 mm
• 04026575230891: Intramedullary Plug, Ø14 mm
• 04026575230884: Intramedullary Plug, Ø13 mm
• 04026575230877: Intramedullary Plug, Ø12 mm
• 04026575036936: Intramedullary Plug Impactor, threaded, L=400 mm, Ø 18 mm
• 04026575036929: Intramedullary Plug Impactor, threaded, L=400 mm, Ø 16 mm
• 04026575036912: Intramedullary Plug Impactor, threaded, L=400 mm, Ø 14 mm
• 04026575036905: Intramedullary Plug Impactor, threaded, L=400 mm, Ø 12 mm
• 04026575036899: Intramedullary Plug Impactor, threaded, L=400 mm, Ø 10 mm
• 04026575036882: Intramedullary Plug Impactor, threaded, L=400 mm, Ø 8 mm
• 04026575036875: Intramedullary Plug Impactor, unthreaded, L=383 mm, Ø 18 mm
• 04026575036868: Intramedullary Plug Impactor, unthreaded, L=383 mm, Ø 16 mm
• 04026575036851: Intramedullary Plug Impactor, unthreaded, L=383 mm, Ø 14 mm
• 04026575036844: Intramedullary Plug Impactor, unthreaded, L=383 mm, Ø 12 mm
• 04026575036837: Intramedullary Plug Impactor, unthreaded, L=383 mm, Ø 10 mm
• 04026575036820: Intramedullary Plug Impactor, unthreaded, L=383 mm, Ø 8 mm