Hercules Suture Anchor System

GUDID 00810021860213

Hercules™ FT Suture Anchor, 2.5 mm x 7.5 mm with two 2-0 BightForce Suture and tapered 1/2 circle needles

IN2BONES USA, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00810021860213
• NIH Device Record Key: 60dff1f0-dea6-4246-b485-c2cbd7964086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hercules Suture Anchor System
• Version Model Number: A20 SP225
• Company DUNS: 079700711
• Company Name: IN2BONES USA, 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: 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	00810021860213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201636

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: 2020-12-22
• Device Publish Date: 2020-12-14

On-Brand Devices [Hercules Suture Anchor System]

• 00810021860244: Hercules™ FT Suture Anchor, 5.5 mm x 16.5 mm with two #2 BightForce Suture and tapered 1/2 ci
• 00810021860237: Hercules™ FT Suture Anchor, 4.5 mm x 13.5 mm with two #2 BightForce Suture and tapered 1/2 ci
• 00810021860220: Hercules™ FT Suture Anchor, 3.5 mm x 10.5 mm with two #0 BightForce Suture and tapered 1/2 ci
• 00810021860213: Hercules™ FT Suture Anchor, 2.5 mm x 7.5 mm with two 2-0 BightForce Suture and tapered 1/2 ci
• 00810021860206: Hercules™ FT Suture Anchor, 2.0 mm x 6.5 mm with two 3-0 BightForce Suture and tapered 1/2 ci
• 00810021860190: Hercules™ Knotless Anchor, 5.5 mm x 19.5 mm
• 00810021860183: Hercules™ Knotless Anchor, 4.5 mm x 15.5 mm
• 00810021860176: Hercules™ Knotless Suture Anchor, 3.5 mm x 12 mm
• 00810021860169: Hercules™ Knotless Suture Anchor, 2.5 mm x 8.6 mm