PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K111135
Device Name PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
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 888.3060
Classification Product Code
KWQ  
Date Received 04/22/2011
Decision Date 08/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No