LCU Hip Stem

GUDID 04026575415335

Hip Prosthesis Stem, Taper 12 / 14

WALDEMAR LINK GmbH & Co. KG

Coated hip femur prosthesis, modular

• Primary Device ID: 04026575415335
• NIH Device Record Key: 355d4e31-7d38-4cb5-b5cc-2fb0b0ddb99f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LCU Hip Stem
• Version Model Number: 165-017/26
• 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: true
• 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	04026575415335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161840

FDA Product Code

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

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: 2023-04-24
• Device Publish Date: 2017-05-16

On-Brand Devices [LCU Hip Stem]

• 04026575436422: Hip Prosthesis Stem, Taper 12 / 14
• 04026575436415: Hip Prosthesis Stem, Taper 12 / 14
• 04026575436378: Hip Prosthesis Stem, Taper 12 / 14
• 04026575436361: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433698: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433681: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433674: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433667: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433650: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433643: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433636: Hip Prosthesis Stem, Taper 12 / 14
• 04026575433629: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415366: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415359: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415342: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415335: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415328: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415311: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415304: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415298: Hip Prosthesis Stem, Taper 12 / 14
• 04026575415281: Hip Prosthesis Stem, Taper 12 / 14