510(k) Premarket Notification

• Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• 510(K) Number: K121024
• Device Name: LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8
• Applicant: ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin, TX 78758
• Contact: william garzon
• Regulation Number: 888.3358
• Classification Product Code: LPH
• Subsequent Product Codes: JDG JDI LZO
• Date Received: 04/04/2012
• Decision Date: 06/19/2012
• 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