Mectacer Biolox Option Heads

GUDID 07630030809347

Head Biolox Option ø 36

Medacta International SA

Ceramic femoral head prosthesis

• Primary Device ID: 07630030809347
• NIH Device Record Key: 3e4cb8b2-f756-4c94-9a49-3eee6d077e03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mectacer Biolox Option Heads
• Version Model Number: 01.29.232H
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030809347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131518

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: 2014-11-18

On-Brand Devices [Mectacer Biolox Option Heads]

• 07630030809408: Sleeve Size XL
• 07630030809392: Sleeve Size L
• 07630030809385: Sleeve Size M
• 07630030809378: Sleeve Size S
• 07630030809361: Head Biolox Option ø 44
• 07630030809354: Head Biolox Option ø 40
• 07630030809347: Head Biolox Option ø 36
• 07630030809330: Head Biolox Option ø 32
• 07630030809323: Head Biolox Option ø 28