SELEX® / M2A-MAGNUM™ HIP SYSTEM S001140

GUDID 00880304993402

Biomet Orthopedics, LLC

Metallic femoral head prosthesis

• Primary Device ID: 00880304993402
• NIH Device Record Key: 5b350c61-04f3-4a81-9d81-0e03ab970b39
• 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	00880304993402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042037

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: 4
• Public Version Date: 2019-11-18
• Device Publish Date: 2017-10-06

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

• 00880304993457: S991140
• 00880304993440: S661140
• 00880304993433: S331140
• 00880304993426: S061140
• 00880304993419: S031140
• 00880304993402: S001140