510(k) Premarket Notification

• Device Classification Name: prosthesis, hip, semi-constrained (metal uncemented acetabular component)
• 510(K) Number: K082239
• Device Name: DEPUY C-STEM AMT
• Applicant: DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw, IN 46582
• Contact: rhonda myer
• Regulation Number: 888.3330
• Classification Product Code: KWA
• Subsequent Product Codes: JDI LPH LZO
• Date Received: 08/07/2008
• Decision Date: 08/29/2008
• 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