510(k) Premarket Notification

• Device Classification Name: plate, fixation, bone
• 510(K) Number: K050512
• Device Name: STRYKER LOCKED PLATING SYSTEM
• Applicant: HOWMEDICA OSTEONICS CORP.; 325 corporate drive; mahwah, NJ 07430
• Contact: vivian kelly
• Regulation Number: 888.3030
• Classification Product Code: HRS
• Subsequent Product Code: HWC
• Date Received: 03/01/2005
• Decision Date: 03/21/2005
• 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