510(k) Premarket Notification

• Device Classification Name: arthroscope
• 510(K) Number: K121893
• Device Name: STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
• Applicant: STRYKER ENDOSCOPY; 5900 optical ct.; san jose, CA 95138
• Contact: lifei liu
• Regulation Number: 888.1100
• Classification Product Code: HRX
• Subsequent Product Code: KOG
• Date Received: 06/29/2012
• Decision Date: 09/05/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Traditional
• Reviewed by Third Party: Yes
• Expedited Review: No
• Combination Product: No