ASCENT KNEE SYSTEM


definition

Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K002678
Device Name ASCENT KNEE SYSTEM
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact dalene t binkley
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 08/28/2000
Decision Date 09/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No