M2a Magnum™ Hip System US157850

GUDID 00880304993495

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00880304993495
• NIH Device Record Key: b41a45ca-d83b-4ebc-bdc9-bcff3563a71a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M2a Magnum™ Hip System
• Version Model Number: US157850
• Catalog Number: US157850
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304993495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042037

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: 2020-05-05
• Device Publish Date: 2017-10-06

On-Brand Devices [M2a Magnum™ Hip System]

• 00880304993693: US257866
• 00880304993686: US257864
• 00880304993679: US257862
• 00880304993662: US257860
• 00880304993655: US257858
• 00880304993648: US257856
• 00880304993631: US257854
• 00880304993624: US257852
• 00880304993617: US257850
• 00880304993600: US257848
• 00880304993594: US257846
• 00880304993587: US257844
• 00880304993570: US157866
• 00880304993563: US157864
• 00880304993556: US157862
• 00880304993549: US157860
• 00880304993532: US157858
• 00880304993525: US157856
• 00880304993518: US157854
• 00880304993501: US157852
• 00880304993495: US157850
• 00880304993488: US157848
• 00880304993471: US157846
• 00880304993464: US157844