510(k) Premarket Notification

• Device Classification Name: prosthesis, hip, semi-constrained (metal uncemented acetabular component)
• 510(K) Number: K122778
• Device Name: PROFEMUR Z REVISION HIP STEM
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC.; 5677 airline rd.; arlington, TN 38002
• Contact: dean nachtrab
• Regulation Number: 888.3330
• Classification Product Code: KWA
• Subsequent Product Code: JDL
• Date Received: 09/11/2012
• Decision Date: 10/11/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No