Grappler R3FLEX Stabilization System

Basic Information

• Brand Name: Grappler R3FLEX Stabilization System
• Primary DI: 00889795128140
• Version / Model: P82-001-1237-SK
• Catalog Number: P82-001-1237-SK
• Company Name: Paragon 28, Inc.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-08
• Public Version: 2
• Public Version Date: 2025-04-22
• Public Version Status: Update
• Public Device Record Key: 21c48bf9-c1c1-4e1b-bb9e-32892c23964a

Device Description

Grappler R3FLEX Single Implant Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MBI	Fastener, fixation, nondegradable, soft tissue	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44052	Orthopaedic surgical procedure kit, non-medicated, single-use	A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889795128140	GS1

Premarket Submissions

Submission Number	Supplement Number
K240594	000