510(k) Premarket Notification

• Device Classification Name: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
• 510(K) Number: K022985
• Device Name: ASCENDENT ACETABULAR SYSTEM
• Applicant: SULZER ORTHOPEDICS, INC.; 9900 spectrum dr.; austin, TX 78717
• Contact: frances e harrison
• Regulation Number: 888.3353
• Classification Product Code: LZO
• Subsequent Product Codes: JDJ KWA LWJ
• Date Received: 09/09/2002
• Decision Date: 12/05/2002
• 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