Inion FreedomPin™

Basic Information

• Brand Name: Inion FreedomPin™
• Primary DI: 06438408004292
• Version / Model: 1
• Catalog Number: OPA-3240
• Company Name: Inion Oy
• Labeler DUNS: 367994657
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-29
• Public Version: 1
• Public Version Date: 2023-10-09
• Public Version Status: New
• Public Device Record Key: a0358277-681f-4d65-bd2a-a9551fdf3e0e

Device Description

Pin 3.2 x 40 mm

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 Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45037	Orthopaedic bone pin, bioabsorbable	A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438408004292	GS1

Premarket Submissions

Submission Number	Supplement Number
K133932	000