FDA 510(k), K904870, MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON

510(K) Number: K904870
Device Name: MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
Manufacturer: MICHAEL J PAPPAS
Device Classification Name: Prosthesis, Hip, Femoral, Resurfacing
Regulation Number: KXA
Classification Product Code: KXA
Date Received: 10/23/1990
Decision Date: 05/23/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic

98 pages (16 of 114 original pages are fully redacted)