Mallory-Head® Hip System 11-104060

GUDID 00887868264146

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00887868264146
• NIH Device Record Key: 2b806e63-fe4a-4fec-b53e-1098d34faf54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mallory-Head® Hip System
• Version Model Number: 11-104060
• Catalog Number: 11-104060
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868264146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861114

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, 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: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [Mallory-Head® Hip System]

• 00887868307683: 11-104080
• 00887868307676: 11-104078
• 00887868307669: 11-104076
• 00887868307652: 11-104074
• 00887868307645: 11-104072
• 00887868307638: 11-104070
• 00887868307621: 11-104068
• 00887868307614: 11-104066
• 00887868307607: 11-104064
• 00887868307591: 11-104062
• 00887868307584: 11-104060
• 00887868307577: 11-104058
• 00887868307560: 11-104056
• 00887868307553: 11-104054
• 00887868307546: 11-104052
• 00887868307539: 11-104050
• 00887868307522: 11-104048
• 00887868307515: 11-104046
• 00887868307508: 11-104044
• 00887868307492: 11-104042
• 00887868307485: 11-104040
• 00887868264245: 11-104080
• 00887868264238: 11-104078
• 00887868264221: 11-104076
• 00887868264214: 11-104074
• 00887868264207: 11-104072
• 00887868264191: 11-104070
• 00887868264184: 11-104068
• 00887868264177: 11-104066
• 00887868264160: 11-104064
• 00887868264153: 11-104062
• 00887868264146: 11-104060
• 00887868264139: 11-104058
• 00887868264122: 11-104056
• 00887868264115: 11-104054
• 00887868264108: 11-104052
• 00887868264092: 11-104050
• 00887868264085: 11-104048
• 00887868264078: 11-104046
• 00887868264061: 11-104044
• 00887868264054: 11-104042
• 00887868264047: 11-104040