Sirius® Hip System 51-199332

GUDID 00887868261664

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00887868261664
• NIH Device Record Key: 7f3b9f30-a814-470e-88b7-801c1fbacb96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sirius® Hip System
• Version Model Number: 51-199332
• Catalog Number: 51-199332
• 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	00887868261664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130610

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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: 2018-09-17
• Device Publish Date: 2018-08-15

On-Brand Devices [Sirius® Hip System]

• 00887868261763: 51-199352
• 00887868261756: 51-199351
• 00887868261749: 51-199343
• 00887868261732: 51-199342
• 00887868261725: 51-199341
• 00887868261718: 51-199337
• 00887868261701: 51-199336
• 00887868261695: 51-199335
• 00887868261688: 51-199334
• 00887868261671: 51-199333
• 00887868261664: 51-199332
• 00887868261657: 51-199331
• 00887868349775: 596044