Hornet 90-RAA-410210

GUDID 00811714032467

Hornet 5.5mm, 3 Sutures

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714032467
• NIH Device Record Key: 786377aa-f0bd-4e47-b632-f092cb030e39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hornet
• Version Model Number: 90-RAA-410210
• Catalog Number: 90-RAA-410210
• Company DUNS: 002745858
• Company Name: RESPONSIVE 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: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00811714032467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180951

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: 2019-05-22
• Device Publish Date: 2019-05-14

On-Brand Devices [Hornet]

• 00811714030043: Hornet 5.5mm Tap
• 00811714030036: Hornet 4.5mm Tap
• 00811714032467: Hornet 5.5mm, 3 Sutures
• 00811714030029: Hornet 5.5mm, 2 Sutures
• 00811714030012: Hornet Suture Anchor 4.5mm, 2 Sutures
• 00811714034355: Hornet Suture Anchor
• 00811714034331: Hornet Suture Anchor
• 00811714032641: Hornet Tap 5.5mm
• 00811714032634: Hornet Tap 4.5mm
• 00811714032672: Hornet Instrument Set
• 00811714035642: Hornet Tap 5.5mm
• 00811714035635: Hornet Tap 5.5mm