UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED


definition

Device Classification Name

prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer

510(k) Number K000827
Device Name UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
Original Applicant
WALTER ABENDSCHEIN, M.D.
5530 wisconsin ave.
suite 705
chevy chase, 
MD 
20815

Original Contact walter abendschein
Regulation Number 888.3540
Classification Product Code
KRR  
Date Received 03/14/2000
Decision Date 06/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No