SANTORINI SPINAL SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K111294
Device Name SANTORINI 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 888.3060
Classification Product Code
MQP  
Date Received 05/10/2011
Decision Date 01/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No