Endo-Model Saddle Prosthesis 15-8007/11

GUDID 04026575047765

Fixation Screw

WALDEMAR LINK GmbH & Co. KG

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 04026575047765
• NIH Device Record Key: 11c29d6c-f7b6-49b6-806f-7dfba2a77679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Model Saddle Prosthesis
• Version Model Number: 15-8007/11
• Catalog Number: 15-8007/11
• 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	04026575047765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951355

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2015-11-01

On-Brand Devices [Endo-Model Saddle Prosthesis]

• 04026575047840: Setscrews
• 04026575047765: Fixation Screw