Modular Stem, 15-8522/53

GUDID 04026575383801

Modular Stem,

WALDEMAR LINK GmbH & Co. KG

Knee femur stem prosthesis

• Primary Device ID: 04026575383801
• NIH Device Record Key: c0a853eb-cd00-4332-9d56-39438e304938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Stem,
• Version Model Number: 15-8522/53
• Catalog Number: 15-8522/53
• 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	04026575383801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151008

FDA Product Code

• LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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: 2020-04-20
• Device Publish Date: 2015-11-01

On-Brand Devices [Modular Stem,]

• 04026575383894: Modular Stem,
• 04026575383887: Modular Stem,
• 04026575383870: Modular Stem,
• 04026575383863: Modular Stem,
• 04026575383856: Modular Stem,
• 04026575383849: Modular Stem,
• 04026575383832: Modular Stem,
• 04026575383825: Modular Stem,
• 04026575383818: Modular Stem,
• 04026575383801: Modular Stem,
• 04026575383795: Modular Stem,
• 04026575383788: Modular Stem,
• 04026575383771: Modular Stem,
• 04026575381784: Modular Stem,
• 04026575381777: Modular Stem,
• 04026575381746: Modular Stem,