Active Articulation™ Hip System 31-139273

GUDID 00887868258466

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00887868258466
• NIH Device Record Key: 5d796ac7-4173-4099-84c1-07241e2a87a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active Articulation™ Hip System
• Version Model Number: 31-139273
• Catalog Number: 31-139273
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868258466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101336

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

[00887868258466]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-11-13

On-Brand Devices [Active Articulation™ Hip System]

• 00887868268465: 31-139274
• 00887868258466: 31-139273
• 00887868258459: 31-139270