ICONN Revolution Knotless Suture Anchor

GUDID 00860419000295

ICONN ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00860419000295
• NIH Device Record Key: f74e0309-9deb-40a2-bec1-5c29869be845
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICONN Revolution Knotless Suture Anchor
• Version Model Number: 350000
• Company DUNS: 055774745
• Company Name: ICONN ORTHOPEDICS LLC
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860419000295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182264

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00860419000295]

Radiation Sterilization

[00860419000295]

Radiation Sterilization

[00860419000295]

Radiation Sterilization

[00860419000295]

Radiation Sterilization

[00860419000295]

Radiation Sterilization

[00860419000295]

Radiation Sterilization

[00860419000295]

Radiation Sterilization

[00860419000295]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-25
• Device Publish Date: 2025-09-17

On-Brand Devices [ICONN Revolution Knotless Suture Anchor]

• 00860419000295: 350000
• 00860006776015: 355000