10 x 80mm SI Fusion Fastener Cann Sterile

Basic Information

• Brand Name: 10 x 80mm SI Fusion Fastener Cann Sterile
• Primary DI: 00810097801417
• Version / Model: 202-10080-S
• Catalog Number: 202-10080-S
• Company Name: Osteocentric Technologies, Inc.
• Labeler DUNS: 089645059
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-17
• Public Version: 3
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 025eb801-3dd2-4a7e-857c-7ec296d09833

Device Description

10 x 80mm SI Fusion Fastener Cann Sterile

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUR	Sacroiliac Joint Fixation	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61485	Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated	An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810097801417	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161755	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	10	Millimeter
Length	80	Millimeter