MALLORY HEAD HIP SYSTEM 11-104050

GUDID 00880304198678

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00880304198678
• NIH Device Record Key: 4517bafa-87f3-4798-91b7-99be13e01ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MALLORY HEAD HIP SYSTEM
• Version Model Number: 11-104050
• Catalog Number: 11-104050
• 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	00880304198678 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [MALLORY HEAD HIP SYSTEM]

• 00880304225206: 124017
• 00880304225190: 124016
• 00880304225183: 124015
• 00880304225176: 124014
• 00880304225169: 124013
• 00880304225152: 124012
• 00880304225145: 124011
• 00880304225138: 124010
• 00880304225121: 124007
• 00880304225114: 124006
• 00880304225107: 124005
• 00880304225091: 124004
• 00880304225084: 124003
• 00880304225077: 124002
• 00880304225060: 124001
• 00880304225053: 124000
• 00880304198845: 11-104080
• 00880304198838: 11-104078
• 00880304198821: 11-104076
• 00880304198814: 11-104074
• 00880304198807: 11-104072
• 00880304198791: 11-104070
• 00880304198784: 11-104068
• 00880304198777: 11-104066
• 00880304198760: 11-104064
• 00880304198753: 11-104062
• 00880304198746: 11-104060
• 00880304198739: 11-104058
• 00880304198715: 11-104056
• 00880304198692: 11-104054
• 00880304198685: 11-104052
• 00880304198678: 11-104050
• 00880304198661: 11-104048
• 00880304198654: 11-104046
• 00880304198647: 11-104044
• 00880304198630: 11-104042
• 00880304198623: 11-104040
• 00880304058095: CP158127
• 00880304058088: CP158126
• 00880304058071: CP158125