KIRSCHNER HIP SYSTEM 532801000

GUDID 00880304569515

Biomet Orthopedics, LLC

Metallic femoral head prosthesis

• Primary Device ID: 00880304569515
• NIH Device Record Key: d3cf461a-c673-4d40-b603-3bb1a3999e98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIRSCHNER HIP SYSTEM
• Version Model Number: 532801000
• Catalog Number: 532801000
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• 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

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304569515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912922

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [KIRSCHNER HIP SYSTEM]

• 00880304714069: 532205000
• 00880304569584: 533215000
• 00880304569577: 533210000
• 00880304569560: 533205000
• 00880304569553: 533201000
• 00880304569546: 533200000
• 00880304569539: 532810000
• 00880304569522: 532805000
• 00880304569515: 532801000
• 00880304569508: 532800000
• 00880304569492: 532610000
• 00880304569485: 532605000
• 00880304569478: 532600000