SPECTRUM CERVICAL SPINAL SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K022997
Device Name SPECTRUM CERVICAL SPINAL SYSTEM
Original Applicant
SPINAL INNOVATIONS, LLC.
7850 stage hills blvd.
suite 105
bartlett, 
TN 
38133 -4029

Original Contact joseph s clift
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 09/09/2002
Decision Date 12/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No