Small Bone Phantom Intramedullary Nail System

Basic Information

• Brand Name: Small Bone Phantom Intramedullary Nail System
• Primary DI: 00889795038845
• Version / Model: P30-L1-5546
• Catalog Number: P30-L1-5546
• Company Name: PARAGON 28, INC.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-17
• Public Version: 2
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: 9f926d5d-bb65-4c88-bfd4-a6f1d349957e

Device Description

Lapidus Nail, Left, 46mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTW	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44854	Arthrodesis nail, fixed-length	A rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889795038845	GS1

Premarket Submissions

Submission Number	Supplement Number
K182307	000