EVEREST SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K103440
Device Name EVEREST SPINAL SYSTEM
Applicant
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

Applicant Contact nancy giezen
Correspondent
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

Correspodent Contact nancy giezen
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 11/23/2010
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No