510(k) Premarket Notification

• Device Classification Name: rod, fixation, intramedullary and accessories
• 510(K) Number: K113409
• Model: 1732-XXXXS 1735-XXXXS 1722-XXXXXS 1725-XXXXS
• Device Name: S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
• Applicant: HOWMEDICA OSTEONICS CORP.; 325 corporate dr; mahwah, NJ 07430
• Contact: juma hoshino
• Regulation Number: 888.3020
• Classification Product Code: HSB
• Date Received: 11/18/2011
• Decision Date: 02/15/2012
• 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