SELEX / M2A-MAGNUM HIP SYSTEM S001140

GUDID 00880304430822

Biomet Orthopedics, LLC

Metallic femoral head prosthesis

• Primary Device ID: 00880304430822
• NIH Device Record Key: 651c7ee1-5b6b-4923-8818-80a37262cdb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELEX / M2A-MAGNUM HIP SYSTEM
• Version Model Number: S001140
• Catalog Number: S001140
• 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	00880304430822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062997

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: 2015-11-18

On-Brand Devices [SELEX / M2A-MAGNUM HIP SYSTEM]

• 00880304477841: S661140
• 00880304477681: S991140
• 00880304477674: S061140
• 00880304477650: S331140
• 00880304477643: S031140
• 00880304430822: S001140