Super Hornet 910000-4500

GUDID 00811714035413

Super Hornet Suture Anchor 4.5mm, 1 Suture Tape

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714035413
• NIH Device Record Key: e13fdb0c-f865-4e9d-8f3b-1ab6b401b11a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Hornet
• Version Model Number: 910000-4500
• Catalog Number: 910000-4500
• 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	00811714035413 [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: 2021-06-04
• Device Publish Date: 2021-05-27

On-Brand Devices [Super Hornet]

• 00811714035420: Super Hornet Suture Anchor 5.5mm, 1 Suture Tape, 1 Suture
• 00811714035413: Super Hornet Suture Anchor 4.5mm, 1 Suture Tape