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. |
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Device | DEPUY 1 BONE CEMENT |
Generic Name | BONE CEMENT |
Regulation Number | 888.3027 |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 |
PMA Number | P960001 |
Date Received | 01/11/1996 |
Decision Date | 02/11/1997 |
Reclassified Date
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10/14/1999 |
Product Code |
LOD |
Docket Number | 97M-0255 |
Notice Date | 07/02/1997 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DEPUY 1 BONE CEMENT. THIS DEVICE IS INDICATED FOR THE FIXATION OF PROSTHESES TO LIVING BONE IN ORTHOPEDIC MUSCULOSKELETAL SURGICAL PROCEDURES FOR THEUMATOID ARTHRITIS, OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, OSTEOPOROSIS, AVASCULAR NECROSIS, COLLAGEN DISEASE, SEVERE JOINT DESTRUCTION SECONDARY TO TRAUMA OR OTHER CONDITIONS AND REVISION OF PREVIOUS ARTHOROPLASTY. |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 |
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