ASCEND SPINAL FIXATION SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K002069
Device Name ASCEND SPINAL FIXATION SYSTEM
Original Applicant
SPINAL INNOVATIONS, LLC.
7850 stage hills blvd.
suite 105
bartlett, 
TN 
38133

Original Contact ken russell
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received 07/07/2000
Decision Date 10/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No