510(k) Premarket Notification

• Device Classification Name: neurological stereotaxic instrument
• 510(K) Number: K122211
• Device Name: SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
• Applicant: SYNTHES SPINE; 1302 wrights ln east; west chester, PA 19380
• Contact: hemal mehta
• Regulation Number: 882.4560
• Classification Product Code: HAW
• Subsequent Product Code: OLO
• Date Received: 07/25/2012
• Decision Date: 12/17/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Neurology
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No