ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01


Device Classification Name

spinal vertebral body replacement device

510(k) Number K080024
Device Name ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
Applicant
K2M, INC.
751 miller dr. se, suite f1
leesburg, 
VA 
20175

Applicant Contact richard w woods
Correspondent
K2M, INC.
751 miller dr. se, suite f1
leesburg, 
VA 
20175

Correspodent Contact richard w woods
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 01/04/2008
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No