Grappler R3FLEX Stabilization System P82-001-1237-SK

GUDID 00889795128140

Grappler R3FLEX Single Implant Kit

PARAGON 28, INC.

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00889795128140
• NIH Device Record Key: 21c48bf9-c1c1-4e1b-bb9e-32892c23964a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grappler R3FLEX Stabilization System
• Version Model Number: P82-001-1237-SK
• Catalog Number: P82-001-1237-SK
• 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: true
• 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	00889795128140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240594

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: 2024-07-16
• Device Publish Date: 2024-07-08

Devices Manufactured by PARAGON 28, INC.

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• 00889795099679 - Baby Gorilla® / Gorilla® Plating System: 2025-04-25 Gorilla®, R3CON™ Screw, Ø2.7 x 58mm, Non-Locking, Solid, TiA
• 00889795099686 - Baby Gorilla® / Gorilla® Plating System: 2025-04-25 Gorilla®, R3CON™ Screw, Ø2.7 x 60mm, Non-Locking, Solid, TiA
• 00889795141439 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Targeting Guide Assembly
• 00889795141446 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Talar Carriage Assembly
• 00889795141460 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Sustentaculum Wire Guide
• 00889795141477 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Talar Wire Guide
• 00889795141491 - Grappler Interference Screw System: 2025-04-25 PCFD Tether, Sinus Tarsai Dilator