NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA


information about

Device Classification Name

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

510(k) Number K002335
Device Name NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
Original Applicant
SULZER ORTHOPEDICS, INC.
9900 spectrum dr.
austin, 
TX 
78717

Original Contact mitchell dhority
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 08/01/2000
Decision Date 10/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized