510(k) Premarket Notification

• Device Classification Name: prosthesis, shoulder, semi-constrained, metal/polymer cemented
• 510(K) Number: K120174
• Device Name: DEPUT DELTA XTEND REVERSE SHOULDER
• Applicant: DEPUY FRANCE; 700 orthopaedic drive; warsaw, IN 46580
• Contact: megan burns
• Regulation Number: 888.3660
• Classification Product Code: KWS
• Subsequent Product Code: HSD
• Date Received: 01/20/2012
• Decision Date: 06/11/2012
• 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