MectaLock PEEK Suture Anchor

GUDID 07630040727815

MectaLock PEEK Ø2.9 – Long driver

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

• Primary Device ID: 07630040727815
• NIH Device Record Key: 02bcbbc6-f49b-4ac5-bfea-1cd1519e8d63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaLock PEEK Suture Anchor
• Version Model Number: 05.11.002
• 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	07630040727815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190474

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 PEEK Suture Anchor]

• 07630345701466: MectaLock PEEK - Ø6.5 - Short driver
• 07630345701459: MectaLock PEEK - Ø5.5 - Short driver
• 07630345701442: MectaLock PEEK - Ø4.5 - Short driver
• 07630040727822: MectaLock PEEK Ø3.4 – Long driver
• 07630040727815: MectaLock PEEK Ø2.9 – Long driver
• 07630040727808: MectaLock PEEK Ø2.4 – Long driver
• 07630040727778: MectaLock PEEK Ø3.4 – Short driver
• 07630040727761: MectaLock PEEK Ø2.9 – Short driver
• 07630040727754: MectaLock PEEK Ø2.4 – Short driver