MotoBAND™ CP DynaForce®

Basic Information

• Brand Name: MotoBAND™ CP DynaForce®
• Primary DI: 00815432028917
• Version / Model: Anti-Drift Bolt Reamer Kit Pack-Out
• Catalog Number: 1500-4851
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Labeler DUNS: 058864308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-28
• Public Version: 4
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 57404a8c-cd24-40bc-962c-bcfcd447a0ce

Device Description

The MotoBAND™ CP DynaForce® Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. Certain plates in the system are compatible with the MotoCLIP/DynaForce Superelastic Fixation System.

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61807	Bone-resection orthopaedic reamer, single-use	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 single-use device.	No	Active
61806	Bone-resection orthopaedic reamer, reprocessed	An orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815432028917	GS1

Customer Contacts

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