RANGE SPINAL SYSTEM, LARGE DENALI SCREWS


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K081381
Device Name RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
Applicant
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

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

Correspodent Contact richard w woods
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received 05/16/2008
Decision Date 06/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No