510(k) Premarket Notification

• Device Classification Name: prosthesis, hip, semi-constrained (metal uncemented acetabular component)
• 510(K) Number: K043099
• Device Name: LINEAGE HA ACETABULAR SHELLS
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC.; 5677 airline rd.; arlington, TN 38002
• Contact: jeanine h redden
• Regulation Number: 888.3330
• Classification Product Code: KWA
• Subsequent Product Codes: LPH MEH
• Date Received: 11/09/2004
• Decision Date: 09/29/2005
• 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