RingLoc® Bi-Polar CP157441

GUDID 00880304057876

Biomet Orthopedics, LLC

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 00880304057876
• NIH Device Record Key: 3f25a7e4-d2ac-4b7f-85ed-9dd054f2244b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RingLoc® Bi-Polar
• Version Model Number: CP157441
• Catalog Number: CP157441
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304057876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051569

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

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: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [RingLoc® Bi-Polar]

• 00880304057982: CP157452
• 00880304057975: CP157451
• 00880304057951: CP157449
• 00880304057944: CP157448
• 00880304057937: CP157447
• 00880304057920: CP157446
• 00880304057913: CP157445
• 00880304057906: CP157444
• 00880304057890: CP157443
• 00880304057883: CP157442
• 00880304057876: CP157441
• 00880304053526: CP155477
• 00880304053519: CP155476
• 00887868474651: 31-165341
• 00887868474644: 31-165340
• 00887868474637: 31-165330
• 00887868474620: 31-165326
• 00887868474613: 31-165320
• 00887868561139: 31-165316
• 00887868561122: 31-165310
• 00887868561115: 31-165308
• 00887868561108: 31-165306