MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K023644
Device Name MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
Original Applicant
SPINAL CONCEPTS, INC.
12012 technology blvd., #100
austin, 
TX 
78727

Original Contact audrey swearingen
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received 10/30/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls