SMISSON STABILIZATION SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K021979
Device Name SMISSON STABILIZATION SYSTEM
Original Applicant
SMISSON-CARTLEDGE
3722 ave. sausalito
irvine, 
CA 
92606

Original Contact grace holland
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 06/17/2002
Decision Date 06/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No