DynaForce 1500-SPSK

GUDID 00850038154301

The MotoBAND® CP Implant System is 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. When used for these indications, the MotoBAND® CP Implant System with the exception of the 2-hole plate may be used with the MotoCLIP®/HiMAX® Implant System.

CROSSROADS EXTREMITY SYSTEMS

Bone-resection orthopaedic reamer, single-use

• Primary Device ID: 00850038154301
• NIH Device Record Key: fb4b461b-d6f7-4f73-a3d6-284e7ca7a3aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaForce
• Version Model Number: 1500-SPSK
• Catalog Number: 1500-SPSK
• Company DUNS: 058864308
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850038154301 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-01-30

On-Brand Devices [DynaForce]

• 00815432026326: MotoCLIP/HiMAX Implant System is a Nitinol Superelastic bone staple for use in surgery of the ha
• 00815432026128: MotoCLIP/HiMAX Implant System is a Nitinol Superelastic bone staple for use in surgery of the ha
• 00815432026111: MotoCLIP/HiMAX Implant System is a Nitinol Superelastic bone staple for use in surgery of the ha
• 00815432026104: MotoCLIP/HiMAX Implant System is a Nitinol Superelastic bone staple for use in surgery of the ha
• 00850038154301: The MotoBAND® CP Implant System is indicated for stabilization and fixation of fresh fractures,
• 00810112597967: gSource H8 Retaining Driver
• 00810112597905: CrossRoads AO Driver Handle Assembly
• 00810112597738: DynaForce, Drill Guide, 15mm STD
• 00810112597721: DynaForce, Drill Guide, 9mm STD
• 00810112597714: DynaForce, Drill Guide, 12mm STD
• 00810112597622: DynaForce, Standard Inserter, 9mm
• 00810112597615: DynaForce Staple Instruments Tray
• 00810112597592: DynaForce, Standard Inserter, 15mm-S
• 00810112597585: DynaForce, Standard Inserter, 12mm
• 00810112597561: DynaForce Temporary Fixation Pin 2.7mm