STERN FIX

Basic Information

• Brand Name: STERN FIX
• Primary DI: 08437006085441
• Version / Model: SC010111
• Company Name: NEOS SURGERY SL
• Labeler DUNS: 465890437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-01
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: acfb5f09-854a-44d0-b0d7-cba2dea3438f

Device Description

STERN FIX Sternal Stabilization System, Size 1

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: 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
JDQ	Cerclage, Fixation	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34017	Sternal fixation device	A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28437006085445	GS1		64	In Commercial Distribution
Primary	08437006085441	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221795	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			size 1