T2

Basic Information

• Brand Name: T2
• Primary DI: 07613153297291
• Version / Model: 1829-1112S
• Catalog Number: 1829-1112S
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 7
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 4d161d6d-a8dc-4e10-af65-37cb62a8f601

Device Description

Arthrodesis Nail, LEFT

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	Orthopedic	888.3020	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	07613153297291	GS1

Premarket Submissions

Submission Number	Supplement Number
K020384	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter: 11.5 Millimeter
Length	620.0	Millimeter