MectaLock All-Suture Anchor

GUDID 07630971259126

MectaLock All-Suture Anchor Size 1 – Long – USP#2 / Tape

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 07630971259126
• NIH Device Record Key: c9dbd57f-bfa8-4f5c-9d8b-9a157107d5dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaLock All-Suture Anchor
• Version Model Number: 05.11.013
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	07630971259126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193461

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-02-10

On-Brand Devices [MectaLock All-Suture Anchor]

• 07630971259140: MectaLock All-Suture Anchor Size 2 – Short – USP#2 / Tape
• 07630971259133: MectaLock All-Suture Anchor Size 2 – Short – 2x USP#2
• 07630971259126: MectaLock All-Suture Anchor Size 1 – Long – USP#2 / Tape
• 07630971259119: MectaLock All-Suture Anchor Size 1 – Short – USP#2 / Tape
• 07630971259102: MectaLock All-Suture Anchor Size 1 – Long– 2x USP#2
• 07630971259096: MectaLock All-Suture Anchor Size 1 – Short – 2x USP#2