510(k) Premarket Notification

• Device Classification Name: plate, fixation, bone
• 510(K) Number: K063020
• Device Name: INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM
• Applicant: INTAI TECHNOLOGY INC.; 4230 east airport drive; suite 110; ontario, CA 91761
• Contact: piewen lin
• Regulation Number: 888.3030
• Classification Product Code: HRS
• Subsequent Product Codes: HWC KTT
• Date Received: 10/02/2006
• Decision Date: 12/14/2006
• 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