ACTIVE ARTICULATION HIP SYSTEM EP-200162

GUDID 00880304485112

Biomet Orthopedics, LLC

Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner Constrained polyethylene acetabular liner

• Primary Device ID: 00880304485112
• NIH Device Record Key: ed07fe21-b028-4dcc-a7cb-49951fe523b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIVE ARTICULATION HIP SYSTEM
• Version Model Number: EP-200162
• Catalog Number: EP-200162
• 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
• 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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304485112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101336

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-19
• Device Publish Date: 2015-10-24

On-Brand Devices [ACTIVE ARTICULATION HIP SYSTEM]

• 00880304491434: XL-200166
• 00880304491427: XL-200164
• 00880304491410: XL-200162
• 00880304491403: XL-200160
• 00880304491397: XL-200158
• 00880304491380: XL-200156
• 00880304491373: XL-200154
• 00880304491366: XL-200152
• 00880304491359: XL-200150
• 00880304491342: XL-200148
• 00880304491335: XL-200146
• 00880304491328: XL-200144
• 00880304485136: EP-200166
• 00880304485129: EP-200164
• 00880304485112: EP-200162
• 00880304485105: EP-200160
• 00880304485099: EP-200158
• 00880304485082: EP-200156
• 00880304485075: EP-200154
• 00880304485068: EP-200152
• 00880304485051: EP-200150
• 00880304485044: EP-200148
• 00880304485037: EP-200146
• 00880304485020: EP-200144