MectaLock TI Suture Anchor

GUDID 07630040727785

MectaLock TI Ø5.0

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 07630040727785
• NIH Device Record Key: 0791fde9-b897-497e-8352-1f7ee8e58cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaLock TI Suture Anchor
• Version Model Number: 05.10.011
• 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	07630040727785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191300

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: 2021-03-04
• Device Publish Date: 2021-02-24

On-Brand Devices [MectaLock TI Suture Anchor]

• 07630040727792: MectaLock TI Ø6.5
• 07630040727785: MectaLock TI Ø5.0