Grappler Suture Anchor System P44-300-4515-SK

GUDID 00889795124258

Knotless Anchor, 4.5mm PEEK + Bridgeline Tape, Sterile Procedure Kit

Paragon 28, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889795124258
• NIH Device Record Key: 178eb0f0-d2ab-4018-b31b-2dcbe06d9340
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grappler Suture Anchor System
• Version Model Number: P44-300-4515-SK
• Catalog Number: P44-300-4515-SK
• Company DUNS: 042961576
• Company Name: Paragon 28, Inc.
• 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: true
• Device Combination Product: true
• 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	00889795124258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211002

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-04-22
• Device Publish Date: 2023-01-27

On-Brand Devices [Grappler Suture Anchor System]

• 00889795128041: Grappler ExO, ø4.75mm x 20mm Dynamic Knotless Anchor, Sterile Kit
• 00889795128034: Grappler ExO, ø2.8mm All-Suture Anchor, Sterile Kit
• 00889795128027: Grappler ExO, ø4.5mm x 15mm Titanium Anchor, Sterile Kit
• 00889795128010: Grappler ExO R3INFORCE, Screwless Head Locking Anchor, Sterile Kit
• 00889795128003: Grappler ExO R3INFORCE, ø4.2mm x 12mm Locking Anchor, Sterile Kit
• 00889795124265: 4.5mm Knotless PEEK + Adaptive Bridgeline, Combo Box
• 00889795124258: Knotless Anchor, 4.5mm PEEK + Bridgeline Tape, Sterile Procedure Kit