510(k) Premarket Notification

• Device Classification Name: plate, fixation, bone
• 510(K) Number: K031666
• Device Name: ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
• Applicant: ARTHREX, INC.; 2885 south horseshoe dr.; naples, FL 34104
• Contact: ann waterhouse
• Regulation Number: 888.3030
• Classification Product Code: HRS
• Subsequent Product Code: GAT
• Date Received: 06/03/2003
• Decision Date: 11/18/2003
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No