CAPSURE PS (R) SPINE SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K081228
Device Name CAPSURE PS (R) SPINE SYSTEM
Applicant
SPINE WAVE, INC.
two enterprise dr.
suite 302
shelton, 
CT 
06484

Applicant Contact roaida rizkallah
Correspondent
SPINE WAVE, INC.
two enterprise dr.
suite 302
shelton, 
CT 
06484

Correspodent Contact roaida rizkallah
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 04/30/2008
Decision Date 05/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No