Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: OSTEOBOND(TM) COPOLYMER BONE CEMENT
• Generic Name: BONE CEMENT
• Regulation Number: 888.3027
• Applicant: ZIMMER, INC.; P.O. Box 708; Warsaw, IN 46581-0708
• PMA Number: N17755
• Supplement Number: S049
• Date Received: 05/01/1997
• Decision Date: 09/05/1997
• Reclassified Date: 10/14/1999
• Product Code: LOD
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for the addition of a second location to manufacture Osteobond Copolymer Bone Cement.