Mini Superhawk Suture Anchor 285981

GUDID 00811714036748

Mini Superhawk 3.75mm End Suture Anchor

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714036748
• NIH Device Record Key: 175c3cf7-7778-4256-93d9-c41ade2fada0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini Superhawk Suture Anchor
• Version Model Number: 285981
• Catalog Number: 285981
• Company DUNS: 002745858
• Company Name: RESPONSIVE ORTHOPEDICS LLC
• 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: true
• 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	00811714036748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253010

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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [Mini Superhawk Suture Anchor]

• 00811714036748: Mini Superhawk 3.75mm End Suture Anchor
• 00811714036625: Mini Superhawk 3.75mm 3.75mm Suture Anchor