510(k) Premarket Notification

• Device Classification Name: plate, bone
• 510(K) Number: K122313
• Device Name: STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
• Applicant: STRYKER; 750 trade centre way; ste 200; portage, MI 49002
• Contact: rob yamashita
• Regulation Number: 872.4760
• Classification Product Code: JEY
• Subsequent Product Code: DZL
• Date Received: 08/02/2012
• Decision Date: 10/31/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Dental
• Review Advisory Committee: Dental
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No