RANGE SPINAL SYSTEM (MESA AND DENALI)


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K112037
Device Name RANGE SPINAL SYSTEM (MESA AND DENALI)
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 Codes
KWP   MNH  
Date Received 07/18/2011
Decision Date 10/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No