FairFix Adjustable Button System

GUDID 07630345703927

FairFix Adjustable Button

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 07630345703927
• NIH Device Record Key: 5a2d7c67-08be-477e-9a9c-5166c425ebc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FairFix Adjustable Button System
• Version Model Number: 05.05.0091
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	07630345703927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203259

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [FairFix Adjustable Button System]

• 07630345703934: FairFix Adjustable Button Extender
• 07630345703927: FairFix Adjustable Button
• 07630345778703: FairFix PSP Adjustable Button
• 07630345778697: FairFix AM Adjustable Button
• 07630345797032: FairFix Round Extender - Large
• 07630345797025: FairFix Round Extender - Medium
• 07630345797018: FairFix Round Extender - Small