Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: OSTEOBOND(TM) COPOLYMER BONE CEMENT
• Classification Name: bone cement
• Generic Name: bone cement
• Regulation Number: 888.3027
• Applicant: ZIMMER, INC.
• PMA Number: N17755
• Supplement Number: S049
• Date Received: 05/01/1997
• Decision Date: 09/05/1997
• Product Code: LOD [ Registered Establishments with LOD ]
• Advisory Committee: Orthopedic
• Supplement Type: normal 180 day track
• Supplement Reason: location change: manufacturer
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the addition of a second location to manufacture osteobond copolymer bone cement.