Inion S-1™

Basic Information

• Brand Name: Inion S-1™
• Primary DI: M224SPN52019
• Version / Model: 1
• Catalog Number: SPN-5201
• Company Name: Inion Oy
• Labeler DUNS: 367994657
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-07
• Public Version: 8
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 61dac19e-80b7-4012-a1b9-a26a7d924ef9
• Distribution End Date: 2023-12-31

Device Description

4.5 x 14 mm screw (4 x)

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: 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
OJB	Resorbable spinal intervertebral body fixation orthosis - plate	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46650	Spinal bone screw, bioabsorbable	A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device is available in various types, including pedicle and transfacet, and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M224SPN52019	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K051821	000