Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: ZIMMER(R) BONE CEMENT
• Classification Name: bone cement
• Generic Name: bone cement
• Regulation Number: 888.3027
• Applicant: ZIMMER, INC.
• PMA Number: N17755
• Date Received: 05/17/1976
• Decision Date: 05/17/1976
• Reclassified Date: 10/14/1999
• Product Code: LOD [ Registered Establishments with 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