CADENCE PEEK CEMEENT RESTRICTOR


Device Classification Name

prosthesis, hip, cement restrictor

510(k) Number K023647
Device Name CADENCE PEEK CEMEENT RESTRICTOR
Original Applicant
SPINAL CONCEPTS, INC.
12012 technology blvd., #100
austin, 
TX 
78727

Original Contact audrey swearingen
Regulation Number 878.3300
Classification Product Code
JDK  
Date Received 10/30/2002
Decision Date 11/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No