CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR


Device Classification Name

prosthesis, hip, cement restrictor

510(k) Number K022615
Device Name CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
Original Applicant
CENTERPULSE SPINE-TECH, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439 -3037

Original Contact angela byland
Regulation Number 878.3300
Classification Product Code
JDK  
Date Received 08/07/2002
Decision Date 10/29/2002
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No