Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780242789
• Version / Model: CCR8950221
• Catalog Number: CCR-895-02-21
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-30
• Public Version: 7
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 906f172c-247e-4e38-9450-ebcdd0894003
• Distribution End Date: 2026-12-31

Device Description

Integra® Total Foot System Cone Spherical Reamer Sz. 21mm The Cone cannulated reamer is intended for preparing the MTP joint for fusion and providing an accurate anatomic fit.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
HTO	REAMER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45114	Bone-resection orthopaedic reamer, reusable	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269CCR89502211	HIBCC
Primary	10381780242789	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.33 in L x .789 in dia