CrossTIE™

Basic Information

• Brand Name: CrossTIE™
• Primary DI: 00815432022045
• Version / Model: 2.5mm 0Deg w/ Universal Inserter
• Catalog Number: 1443-2501
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Labeler DUNS: 058864308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-09
• Public Version: 6
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: a8bd25e6-7c8d-4a0b-aea3-98f83b2a2fb8

Device Description

Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12696	Orthopaedic implant inserter/extractor, reusable	A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.	No	Active
46646	Orthopaedic bone screw, non-bioabsorbable, sterile	A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815432022045	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.5mm x 17mm x 0degree