ICONN Answer II 5.5MM Suture Anchor

GUDID 00860419000264

ICONN ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00860419000264
• NIH Device Record Key: 937aa071-d17f-4fb7-b888-c1ee3d8c4fa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICONN Answer II 5.5MM Suture Anchor
• Version Model Number: 155001
• 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	00860419000264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181680

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00860419000264]

Radiation Sterilization

[00860419000264]

Radiation Sterilization

[00860419000264]

Radiation Sterilization

[00860419000264]

Radiation Sterilization

[00860419000264]

Radiation Sterilization

[00860419000264]

Radiation Sterilization

[00860419000264]

Radiation Sterilization

[00860419000264]

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

Devices Manufactured by ICONN ORTHOPEDICS LLC

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• 00860006776022 - ICONN Square Suture Anchor Knotless: 2025-09-25
• 00860419000226 - ICONN Square 2.5MM Suture Anchor: 2025-09-25
• 00860419000257 - ICONN Answer II 4.75MM Suture Anchor: 2025-09-25
• 00860419000264 - ICONN Answer II 5.5MM Suture Anchor: 2025-09-25
• 00860419000264 - ICONN Answer II 5.5MM Suture Anchor: 2025-09-25
• 00860419000271 - ICONN Answer II 6.5MM Suture Anchor: 2025-09-25
• 00860419000295 - ICONN Revolution Knotless Suture Anchor: 2025-09-25
• 00860419000202 - ICONN Answer 4.75MM Suture Anchor: 2019-03-21 ICONN Answer 4.75MM Suture Anchor