ECHO FX HIP SYSTEM 12-151415

GUDID 00880304520301

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00880304520301
• NIH Device Record Key: be521db3-a579-47fa-8381-a7212a93eef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHO FX HIP SYSTEM
• Version Model Number: 12-151415
• Catalog Number: 12-151415
• 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	00880304520301 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [ECHO FX HIP SYSTEM]

• 00880304520325: 12-151417
• 00880304520318: 12-151413
• 00880304520301: 12-151415
• 00880304520295: 12-151409
• 00880304520288: 12-151411
• 00880304467941: 12-151313
• 00880304467934: 12-151315
• 00880304467927: 12-151317
• 00880304467910: 12-151307
• 00880304464162: 12-151311
• 00880304457584: 12-151309