INCOMPASS SPINAL FIXATION SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K021564
Device Name INCOMPASS SPINAL FIXATION SYSTEM
Original Applicant
SPINAL CONCEPTS, INC.
12012 technology blvd., #100
austin, 
TX 
78727

Original Contact david m hooper
Regulation Number 888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 05/13/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No