Global Spinal Fixation System™

Basic Information

• Brand Name: Global Spinal Fixation System™
• Primary DI: 08800015946414
• Version / Model: SG0019
• Company Name: Innosys Co., Ltd.
• Labeler DUNS: 688811082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-02
• Public Version: 4
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 53a089b4-763c-4ab6-8a18-ebab53468096

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWA	IMPACTOR	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47743	Bone graft packing block	A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800015946414	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place.