510(k) Premarket Notification

• Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• 510(K) Number: K121297
• Device Name: ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
• Applicant: SIGNATURE ORTHOPAEDICS, PTY, LTD; 125 greville st; chatswood,
• Contact: declan brazil
• Regulation Number: 888.3358
• Classification Product Code: LPH
• Subsequent Product Code: MEH
• Date Received: 04/30/2012
• Decision Date: 12/28/2012
• 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