Ligament Staple

GUDID 07630971258594

Ligament Staple

Medacta International SA

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 07630971258594
• NIH Device Record Key: d475de43-4393-4e42-9733-bf79fca06453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ligament Staple
• Version Model Number: 05.12.001
• 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	07630971258594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210456

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2021-04-22
• Device Publish Date: 2021-04-14

On-Brand Devices [Ligament Staple]

• 07630971258594: Ligament Staple
• 07630345719133: k-wire KIT for Ligament Staple L105mm