Dynamic Syndesmosis P80-142-1462-S

GUDID 00889795128676

R3ACT Synds Imp 4.2x62mm, 14mm Ntch, St

PARAGON 28, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00889795128676
• NIH Device Record Key: 3c16cae4-a715-48e5-8bd1-310ca51924a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynamic Syndesmosis
• Version Model Number: P80-142-1462-S
• Catalog Number: P80-142-1462-S
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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	00889795128676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190365

FDA Product Code

• HWC: Screw, fixation, bone

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: 2023-05-11
• Device Publish Date: 2023-05-03

On-Brand Devices [Dynamic Syndesmosis]

• 00889795098481: Dynamic Syndesmosis Screw Ø4.2 X 60mm, 17mm Notch, Sterile
• 00889795098474: Dynamic Syndesmosis Screw Ø4.2 X 55mm, 17mm Notch, Sterile
• 00889795098467: Dynamic Syndesmosis Screw Ø4.2 X 50mm, 17mm Notch, Sterile
• 00889795098450: Dynamic Syndesmosis Screw Ø4.2 X 45mm, 17mm Notch, Sterile
• 00889795098443: Dynamic Syndesmosis Screw Ø4.2 X 40mm, 17mm Notch, Sterile
• 00889795098436: Dynamic Syndesmosis Screw Ø4.2 X 60mm, 14mm Notch, Sterile
• 00889795098429: Dynamic Syndesmosis Screw Ø4.2 X 55mm, 14mm Notch, Sterile
• 00889795098412: Dynamic Syndesmosis Screw Ø4.2 X 50mm, 14mm Notch, Sterile
• 00889795098405: Dynamic Syndesmosis Screw Ø4.2 X 45mm, 14mm Notch, Sterile
• 00889795098399: Dynamic Syndesmosis Screw Ø4.2 X 40mm, 14mm Notch, Sterile
• 00889795114433: R3ACT Stablization System Implant, Ø4.2 X 50mm, 15.5mm Notch, Ti-6Al-4V ELI, Sterile
• 00889795114402: R3ACT Stablization System Implant, Ø4.2 X 70mm, 14mm Notch, Ti-6Al-4V ELI, Sterile
• 00889795114396: R3ACT Stablization System Implant, Ø4.2 X 65mm, 14mm Notch, Ti-6Al-4V ELI, Sterile
• 00889795128713: R3ACT Synds Imp 4.2x62mm, 17mm Ntch, St
• 00889795128706: R3ACT Synds Imp 4.2x57mm, 17mm Ntch, St
• 00889795128690: R3ACT Synds Imp 4.2x52mm, 17mm Ntch, St
• 00889795128683: R3ACT Synds Imp 4.2x47mm, 17mm Ntch, St
• 00889795128676: R3ACT Synds Imp 4.2x62mm, 14mm Ntch, St
• 00889795128669: R3ACT Synds Imp 4.2x57mm, 14mm Ntch, St
• 00889795128652: R3ACT Synds Imp 4.2x52mm, 14mm Ntch, St
• 00889795128645: R3ACT Synds Imp 4.2x47mm, 14mm Ntch, St
• 00889795128638: R3ACT Synds Imp 4.2x42mm, 14mm Ntch, St