Echo® Press-Fit Hip System 12-150315

GUDID 00887868261053

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis

• Primary Device ID: 00887868261053
• NIH Device Record Key: 643c1a93-747d-4ab4-b376-e08bd184d182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo® Press-Fit Hip System
• Version Model Number: 12-150315
• Catalog Number: 12-150315
• 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	00887868261053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063002

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® Press-Fit Hip System]

• 00887868261077: 12-150317
• 00887868261060: 12-150316
• 00887868261053: 12-150315
• 00887868261046: 12-150314
• 00887868261039: 12-150313
• 00887868261022: 12-150312
• 00887868261015: 12-150311
• 00887868261008: 12-150310
• 00887868260995: 12-150309
• 00887868260988: 12-150308
• 00887868260971: 12-150307
• 00887868260902: 192515
• 00887868260896: 192514
• 00887868260889: 192513
• 00887868260872: 192512
• 00887868260865: 192511
• 00887868260858: 192510
• 00887868260841: 192509
• 00887868260834: 192508
• 00887868260827: 192421
• 00887868260810: 192420
• 00887868260803: 192419