M2A MAGNUM HIP SYSTEM US257846

GUDID 00880304452695

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00880304452695
• NIH Device Record Key: a7a0b6b8-aa8f-43a0-a95a-81ea12ba8330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M2A MAGNUM HIP SYSTEM
• Version Model Number: US257846
• Catalog Number: US257846
• 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

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	00880304452695 [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: 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 [M2A MAGNUM HIP SYSTEM]

• 00880304652156: US157866
• 00880304652149: US157864
• 00880304652132: US157846
• 00880304554320: 139261
• 00880304554313: 139259
• 00880304542631: US157844
• 00880304452954: US257862
• 00880304452695: US257846
• 00880304452688: US257848
• 00880304452671: US257844
• 00880304452664: US257858
• 00880304452657: US257864
• 00880304452640: US257866
• 00880304452633: US257860
• 00880304452626: US257852
• 00880304452619: US257856
• 00880304451261: US257854
• 00880304449534: US157848
• 00880304449527: US157862
• 00880304449510: US157854
• 00880304449473: US157860
• 00880304449466: US157856
• 00880304449459: US157858
• 00880304449442: US157852
• 00880304449435: US157850
• 00880304448797: US257850
• 00880304428058: 139256
• 00880304428041: 139252
• 00880304428027: 139254
• 00880304428010: 139258
• 00880304428003: 139264
• 00880304427983: 139268
• 00880304427976: 139266
• 00880304427969: 139272
• 00880304427945: 139274
• 00880304427914: 139270
• 00880304607286: 31-158932