510(k) Premarket Notification

• Device Classification Name: plate, fixation, bone
• 510(K) Number: K121494
• Device Name: LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
• Applicant: AAP IMPLANTATE AG; lorenzweg 5; berlin,
• Contact: marc seegers
• Regulation Number: 888.3030
• Classification Product Code: HRS
• Subsequent Product Code: HWC
• Date Received: 05/21/2012
• Decision Date: 11/19/2012
• 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