510(k) Premarket Notification

• Device Classification Name: plate, fixation, bone
• 510(K) Number: K962616
• Device Name: SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
• Applicant: SYNTHES (USA); 1690 russell rd.; post office box 1766; paoli, PA 19301
• Contact: angela j silvestri
• Regulation Number: 888.3030
• Classification Product Code: HRS
• Subsequent Product Code: HWC
• Date Received: 07/03/1996
• Decision Date: 09/03/1996
• Decision: substantially equivalent for some indications (SN)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No