Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: ZIMMER(R) BONE CEMENT
• Generic Name: BONE CEMENT
• Regulation Number: 888.3027
• Applicant: ZIMMER, INC.; P.O. Box 708; Warsaw, IN 46581-0708
• PMA Number: N17755
• Date Received: 05/17/1976
• Decision Date: 05/17/1976
• Reclassified Date: 10/14/1999
• Product Code: LOD
• Advisory Committee: Orthopedic
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S019 S021 S022 S024 S025 S026 S027 S028 S029 S031 S033 S034 ; S035 S036 S037 S039 S040 S041 S042 S043 S044 S045 S046 ; S047 S048 S049