Taperloc® Complete Hip System SSI002770

GUDID 00880304849273

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304849273
• NIH Device Record Key: e209a2ca-9b7b-4819-b86f-27b53818519f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Taperloc® Complete Hip System
• Version Model Number: SSI002770
• Catalog Number: SSI002770
• 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: 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	00880304849273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120030

FDA Product Code

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

Sterilization

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

[00880304849273]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-21

On-Brand Devices [Taperloc® Complete Hip System]

• 00880304849273: SSI002770
• 00880304849266: SSI002769
• 00880304849259: SSI002768
• 00880304849242: SSI002767
• 00880304849235: SSI002766
• 00880304849228: SSI002765
• 00880304761957: 110028057
• 00880304761940: 110018255
• 00880304761933: 110018254
• 00880304761926: 110018253
• 00887868509896: 595541
• 00887868509889: 595540