Echo FX™ Hip System 12-151307

GUDID 00887868261084

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis

• Primary Device ID: 00887868261084
• NIH Device Record Key: a76d2de3-d7f1-4c1e-b204-aed1044330dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo FX™ Hip System
• Version Model Number: 12-151307
• Catalog Number: 12-151307
• 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	00887868261084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063614

FDA Product Code

• MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

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: 2018-08-23
• Device Publish Date: 2018-07-23

On-Brand Devices [Echo FX™ Hip System]

• 00887868261138: 12-151317
• 00887868261121: 12-151315
• 00887868261114: 12-151313
• 00887868261107: 12-151311
• 00887868261091: 12-151309
• 00887868261084: 12-151307
• 00887868260964: 192521
• 00887868260957: 192520
• 00887868260940: 192519
• 00887868260933: 192518
• 00887868260926: 192517
• 00887868260919: 192516