Depuy 1 Bone Cement

FDA premarket approval P960001 · Bone Cement

PMA numberP960001

Approval

Applicant
Depuy, Inc.
Received
January 11, 1996
Decision date
February 11, 1997 (APRL)
Supplements
8, latest September 20, 1999
Product code
LOD – Bone Cement

Official FDA PMA record

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.