Integrity-SI Fusion System

Basic Information

• Brand Name: Integrity-SI Fusion System
• Primary DI: B57112521012056D0
• Version / Model: 1252-1012-056
• Catalog Number: 1252-1012-056
• Company Name: Lincotek Medical LLC
• Labeler DUNS: 117021487
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-09
• Public Version: 4
• Public Version Date: 2023-11-16
• Public Version Status: Update
• Public Device Record Key: ca4a0c21-e930-45ee-be47-a51a8af9528a
• Distribution End Date: 2022-01-24

Device Description

12 x 55 mm SI Implant with HA Coating

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: Yes
• 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
OUR	Sacroiliac Joint Fixation	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58808	Sacroiliac joint transarticular fixation/arthrodesis implant, coated	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 metal [e.g., titanium (Ti)] with a porous plasma spray coating, and typically in the form of a cylinder or rod, possibly with a triangular cross-section. 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	B57112521012056D0	HIBCC

Customer Contacts

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