CASIAN, 3.5/4.5 CONNECTORS


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K121808
Device Name CASIAN, 3.5/4.5 CONNECTORS
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 888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received 06/20/2012
Decision Date 07/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No