CAYMAN BUTTRESS PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K080302
Device Name CAYMAN BUTTRESS PLATE SYSTEM
Applicant
K2M, INC.
751 miller dr.,se
leesburg, 
VA 
20175

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

Correspodent Contact richard woods
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 02/05/2008
Decision Date 03/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No