SIERRA SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K080526
Device Name SIERRA SYSTEM
Applicant
SEASPINE, INC.
2302 la mirada dr.
vista, 
CA 
92081 -7862

Applicant Contact ethel bernal
Correspondent
SEASPINE, INC.
2302 la mirada dr.
vista, 
CA 
92081 -7862

Correspodent Contact ethel bernal
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 02/26/2008
Decision Date 04/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No