ASCENT XXL OPEN BOX FEMORAL COMPONENT


the company

Device Classification Name

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

510(k) Number K002735
Device Name ASCENT XXL OPEN BOX FEMORAL COMPONENT
Original Applicant
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact michelle l mckinley
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 09/01/2000
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