RingLoc® Mallory-Head® Hip System 13-104178

GUDID 00887868308192

Biomet Orthopedics, LLC

Metallic femoral head prosthesis

• Primary Device ID: 00887868308192
• NIH Device Record Key: d1509ac5-36ec-45a9-98c2-f3d32ca5be77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RingLoc® Mallory-Head® Hip System
• Version Model Number: 13-104178
• Catalog Number: 13-104178
• 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	00887868308192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

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: 2019-04-26
• Device Publish Date: 2019-04-18

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

• 00887868308208: 13-104180
• 00887868308192: 13-104178
• 00887868308185: 13-104176
• 00887868308178: 13-104174
• 00887868308161: 13-104172
• 00887868308154: 13-104170
• 00887868308147: 13-104168
• 00887868308130: 13-104166
• 00887868308123: 13-104164
• 00887868308116: 13-104162
• 00887868308109: 13-104160
• 00887868308093: 13-104158
• 00887868308086: 13-104156
• 00887868308079: 13-104154
• 00887868308062: 13-104152
• 00887868308055: 13-104150
• 00887868308048: 13-104148
• 00887868308031: 13-104146
• 00887868308024: 13-104144
• 00887868308017: 13-104142
• 00887868308000: 13-104140
• 00887868311048: 12-104178
• 00887868311031: 12-104176
• 00887868311024: 12-104174
• 00887868311017: 12-104172
• 00887868311000: 12-104170
• 00887868310997: 12-104168
• 00887868310980: 12-104166
• 00887868310973: 12-104164
• 00887868310966: 12-104162
• 00887868310959: 12-104160
• 00887868308840: 13-104080
• 00887868308833: 13-104078
• 00887868308826: 13-104076
• 00887868308819: 13-104074
• 00887868308802: 13-104072
• 00887868308796: 13-104070
• 00887868308789: 13-104068
• 00887868308772: 13-104066
• 00887868308765: 13-104064
• 00887868308758: 13-104062
• 00887868308741: 13-104060
• 00887868308734: 13-104058
• 00887868308727: 13-104056
• 00887868308710: 13-104054
• 00887868308703: 13-104052
• 00887868308697: 13-104050
• 00887868308680: 13-104048
• 00887868308673: 13-104046
• 00887868308666: 13-104044