MESA SPINAL SYSTEM (KEYSTONE RODS)


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K110991
Device Name MESA SPINAL SYSTEM (KEYSTONE RODS)
Applicant
K2M, INC.
751 miller dr.,se
suite f-1
leesburg, 
VA 
20175

Applicant Contact nancy giezen
Correspondent
K2M, INC.
751 miller dr.,se
suite f-1
leesburg, 
VA 
20175

Correspodent Contact nancy giezen
Regulation Number 888.3070
Classification Product Code
MNI  
Date Received 04/08/2011
Decision Date 08/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No