Mectacer Biolox Delta Femoral Ball Head

GUDID 07630030809132

Femoral Head Ø 28 Size M

Medacta International SA

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 07630030809132
• NIH Device Record Key: c33d4d1f-2cfe-4d5b-a2c8-f436d57d9fd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mectacer Biolox Delta Femoral Ball Head
• Version Model Number: 01.29.202
• 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	07630030809132 [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