510(k) Premarket Notification

• Device Classification Name: prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
• 510(K) Number: K121627
• Device Name: SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
• Applicant: SMITH & NEPHEW, INC.; 7135 goodlett farms parkway; cordova, TN 38016
• Contact: natalie p williams
• Regulation Number: 888.3353
• Classification Product Code: MEH
• Subsequent Product Code: LZO
• Date Received: 06/04/2012
• Decision Date: 10/15/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Abbreviated
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No