FORTITUDE CEMENT RESTRICTOR


Device Classification Name

prosthesis, hip, cement restrictor

510(k) Number K021719
Device Name FORTITUDE CEMENT RESTRICTOR
Original Applicant
SPINAL CONCEPTS, INC.
12012 technology blvd., #100
austin, 
TX 
78727

Original Contact david m hooper
Regulation Number 878.3300
Classification Product Code
JDK  
Date Received 05/23/2002
Decision Date 08/15/2002
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No