MotoBAND™ CP DynaForce®

Basic Information

• Brand Name: MotoBAND™ CP DynaForce®
• Primary DI: 00850038154394
• Version / Model: DynaBunion Plate 15mm Left Single Pack
• Catalog Number: 7100-LP15-L
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Labeler DUNS: 058864308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-27
• Public Version: 2
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 0d8f5b36-102c-48c4-9133-aecaea224778

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: 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
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2
JDR	Staple, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61688	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile	A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.	No	Obsolete
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038154394	GS1

Customer Contacts

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