TITAN 3-D Wedge System

Basic Information

• Brand Name: TITAN 3-D Wedge System
• Primary DI: 00889795018182
• Version / Model: P03-EVN-1010-S
• Catalog Number: P03-EVN-1010-S
• Company Name: PARAGON 28, INC.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-16
• Public Version: 2
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: dd6008ac-f4de-4c5a-b346-a3a3ddfb0b20

Device Description

TITAN 3-D Wedge, Evans, Large, 10mm, Sterile

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 Conditional
• 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
PLF	Bone Wedge	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61617	Metallic osteotomy fusion cage, non-customized	A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889795018182	GS1

Premarket Submissions

Submission Number	Supplement Number
K162241	000