CoCr Femoral Ball Head

GUDID 07630030805189

Femoral Head Ø 32 size XL

Medacta International SA

Metallic femoral head prosthesis

• Primary Device ID: 07630030805189
• NIH Device Record Key: 9ab7cd7b-444b-413c-8547-4e3a245ec418
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoCr Femoral Ball Head
• Version Model Number: 01.25.024
• 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	07630030805189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072857

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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: 2020-04-06
• Device Publish Date: 2014-11-18

On-Brand Devices [CoCr Femoral Ball Head]

• 07630030805486: Femoral Head Ø 22 size S
• 07630030805479: Femoral Head Ø 22 size M
• 07630030805370: Femoral Head Ø 40 Size XXL
• 07630030805363: Femoral Head Ø 40 Size XL
• 07630030805356: Femoral Head Ø 40 Size L
• 07630030805349: Femoral Head Ø 40 Size M
• 07630030805332: Femoral Head Ø 40 Size S
• 07630030805240: Femoral Head Ø 36 size XXL
• 07630030805233: Femoral Head Ø 36 size XL
• 07630030805226: Femoral Head Ø 36 size L
• 07630030805219: Femoral Head Ø 36 size M
• 07630030805202: Femoral Head Ø 36 size S
• 07630030805196: Femoral Head Ø 32 size XXL
• 07630030805189: Femoral Head Ø 32 size XL
• 07630030805172: Femoral Head Ø 32 size L
• 07630030805165: Femoral Head Ø 32 size M
• 07630030805158: Femoral Head Ø 32 size S
• 07630030805141: Femoral Head Ø 28 size XXL
• 07630030805134: Femoral Head Ø 28 size XL
• 07630030805127: Femoral Head Ø 28 size L
• 07630030805110: Femoral Head Ø 28 size M
• 07630030805103: Femoral Head Ø 28 size S