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.

• 00889795031594 - Baby Gorilla®/Gorilla® Plating System: 2024-07-16 GORILLA R3CON Washer, Flat/Dome Screw, Ø2.7, Ø3.5 & Ø4.2 STERILE
• 00889795127945 - Baby Gorilla®/Gorilla® Plating System: 2024-07-16 1/3 Tubular Plate, 2 Hole
• 00889795128140 - Grappler R3FLEX Stabilization System: 2024-07-16Grappler R3FLEX Single Implant Kit
• 00889795128140 - Grappler R3FLEX Stabilization System: 2024-07-16 Grappler R3FLEX Single Implant Kit
• 00889795132345 - Baby Gorilla®/Gorilla® Plating System: 2024-07-16 1/3 Tubular Plate, 2 Hole STERILE
• 00889795141217 - APEX 3D Total Ankle Replacement System: 2024-07-09 APEX 3D-PS Total Ankle Replacement System, Small Tray
• 00889795140135 - Bun-Yo-Matic™ Lapidus Clamp System: 2024-06-21 K-wire Tube, 80mm MAX
• 00889795140142 - Bun-Yo-Matic™ Lapidus Clamp System: 2024-06-21 K-wire Tube, 100mm MAX
• 00889795130556 - Baby Gorilla/Gorilla Plating System: 2024-05-20 MTP Instrument Case Base