Mectacer Biolox Delta Femoral Ball Head

GUDID 07630030809293

Femoral Head Ø 44 Size L

Medacta International SA

Ceramic femoral head prosthesis

• Primary Device ID: 07630030809293
• NIH Device Record Key: 1e98128d-eb08-48a6-96d7-abaf8faeed9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mectacer Biolox Delta Femoral Ball Head
• Version Model Number: 01.29.218
• 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	07630030809293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112115

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 Delta Femoral Ball Head]

• 07630030809309: Femoral Head Ø 44 Size XL
• 07630030809293: Femoral Head Ø 44 Size L
• 07630030809286: Femoral Head Ø 44 Size M
• 07630030809279: Femoral Head Ø 44 Size S
• 07630030809262: Femoral Head Ø 40 Size XL
• 07630030809255: Femoral Head Ø 40 Size L
• 07630030809248: Femoral Head Ø 40 Size M
• 07630030809231: Femoral Head Ø 40 Size S
• 07630030809224: Femoral Head Ø 36 Size XL
• 07630030809217: Femoral Head Ø 36 Size L
• 07630030809200: Femoral Head Ø 36 Size M
• 07630030809194: Femoral Head Ø 36 Size S
• 07630030809187: Femoral Head Ø 32 Size XL
• 07630030809170: Femoral Head Ø 32 Size L
• 07630030809163: Femoral Head Ø 32 Size M
• 07630030809156: Femoral Head Ø 32 Size S
• 07630030809149: Femoral Head Ø 28 Size L
• 07630030809132: Femoral Head Ø 28 Size M
• 07630030809125: Femoral Head Ø 28 Size S