Taperloc Complete Hip System SSI003777

GUDID 00880304989191

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00880304989191
• NIH Device Record Key: bab7d4ec-5b62-4317-99de-c668d8793b87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Taperloc Complete Hip System
• Version Model Number: SSI003777
• Catalog Number: SSI003777
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0
• Angle: 45 degree
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304989191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101086

FDA Product Code

• KWA: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Sterilization

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

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

[00880304989191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-05-03

On-Brand Devices [Taperloc Complete Hip System]

• 00880304989191: SSI003777
• 00880304989184: SSI003776
• 00880304907416: SSI003792
• 00880304865792: SSI003774
• 00880304865785: SSI003773
• 00880304856837: SSI003743
• 00880304506992: 595540