Mectacer Biolox Forte Femoral Ball Head

GUDID 07630030846779

Femoral Head Ø 36 Size L

Medacta International SA

Ceramic femoral head prosthesis

• Primary Device ID: 07630030846779
• NIH Device Record Key: 7755dfe0-1f3a-42f1-845e-7835e56c28a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mectacer Biolox Forte Femoral Ball Head
• Version Model Number: 38.39.7176.615.00
• 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	07630030846779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073337

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 Forte Femoral Ball Head]

• 07630030846779: Femoral Head Ø 36 Size L
• 07630030846762: Femoral Head Ø 36 Size M
• 07630030846755: Femoral Head Ø 36 Size S
• 07630030846748: Femoral Head Ø 32 Size L
• 07630030846731: Femoral Head Ø 32 Size M
• 07630030846724: Femoral Head Ø 32 Size S
• 07630030846717: Femoral Head Ø 28 Size L
• 07630030846700: Femoral Head Ø 28 Size M
• 07630030846694: Femoral Head Ø 28 Size S